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1. xv LJ ve T rame ss on e EA SS Me iue AP Sp i DEBT re i pa ROTATE TRANSCUCER HEAD 90 LONGITUDINAL Figure 23 Right Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 68 RIGHT SIDE EXTERMAL INTERNAL SKIN TRANSOUCER HEAD 90 Right Carotid Artery Transverse Scan Investigation Procedure Figure 24 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 69 Ms INTERNAL SKIN EXTERNAL ROTATE R TRANSOUCER HEAD 90 LONGITUDINAL Figure 25 Right Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 70 LEFT SIDE o EXTERNAL SKIN A INTERNAL o x gt bs de p sq Eu Ap M toa Los 2 ES de A V ont st od Sr e h SE LI whe een n CE PL SN de eis fd o a E D LIN E d x OE OE dan 8 E E o TR V aL ON E Up to LIP iv ATEEN 5 A LCS A Ma pre TS Sy Vo 2 ir Ro em 2 n lt 2 o PLN rna a PLI E n n t x e Hi Eu SERE S e oe 5 AY IA Voy Wye ae NC Ta lat HE x ROTATE TRANSOUCEA HEAD 90 es LONGITUDINAL Figure 26 Left Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSI
2. 7 IH A sat Un E Dots E Di 7 t DAR bale e Eu E he 4 1 Periadeventitial adventitial near wall interface 2 Adventitial medial near wall interface 3 Intimal lumen near wall interface 4 Lumen intimal far wall interface 5 Medial adventitial far wall interface 6 Adventitial periadventitial far wall interface Figure 13 Common Carotid Artery all four boundaries visualized ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 32 Right Carotid Bifurcation gatus nif PES RS Li UN MIA lt lt O gd ad vs E gt MET DCN o Mm LE y ial near wall interface advent ial Periadeventi Adventitial medial near wall 4 interface terface 2 3 In lumen near wall intimal far wall Medial advent Advent Intima rface ial far wall in lal periadvent Inte Lumen 4 terface ial far wall interface i 5 6 b The Bifurcation Figure 14 t 3 VERSION 3 0 01 95 isi Ultrasound Scanning Procedures V ARIC PROTOCOL 6a 33 Internal Carotid Artery ouenboeiJ e m TI Internal Carotid Artery External Carotid Artery Doppler Tracing ouenboejJ Figure 15 IRS di Be 21 ime T External Carotid Artery ing Doppler Trac Figure 16 t 3 VERSION 3 0 01 95 isi ARIC PROTOC L 6a Ultrasound Scanning Procedures V
3. Any information pertinent to interpretation of images or following flow of scan equipment problems or imaging problem etc Repeat Codes 1 Actual repeat scans of a site need to be identified on the log sheet only 2 If a code is repeated because the select footswitch was not pressed to advance the flow chart note on the logsheet the circumstances The sites do not need to be repeated Once identified the URC will correct the file to match the images on tape Starting Date and Shipping Number Beginning Shipping Numbers for each field center are as follows Forsyth ARIC FHS FU3001 Jackson ARIC JU3001 Minneapolis ARIC FHS MU3001 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 Hagerstown ARIC WU3001 Login report to Field Center this report acknowledges the receipt of studies and processing is complete for the Login procedures This report is sent weekly The sonographers can delete the studies listed from the studies directory on their PC This needs to be done weekly to prevent hard drive disk space problems ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 LOG SHEET Page pina TILT Sa ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 10 APPENDIX VI VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM THIS END GOES INTO CASE FINST Super VHS SVHS PLACE CASSETTE AND PAN
4. B 12 33 50 BBA13053400130533093082132068 Press B on the IBM keyboard Ready to take blood pressure To CONTINUE Received command to take arm bp Press Y and ENTER on DELL CSA B 12 33 50 BBA13053400130533093082132068 computer l Ready to take blood pressure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 60 Press B on the IBM computer keyboard The screens will now read IBM Computer Monitor Ready to take blood pressure Received command to take arm bp B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Received command to take arm bp After the data has been collected a copy of the data sent to the IBM will be copied onto the IBM monitor The data displayed will look something like this a 486 Computer Monitor IBM Computer Monitor Received command to take arm bp B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Received command to take arm bp B 12 33 50 BBA13053400130533093082132068 After the arm blood pressure is taken and the cuff is fully deflated the IBM screen will read t tne IBM Computer Monitor B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Received command to take arm bp Press Y Y and ENTER on PELL CSA B 12 33 50 BBA13053400130533093082132068 compiiter lt Ready to take blood pressure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3
5. MANUAL ANKLE blood pressure Press M on the IBM keyboard Received command to take manual bp When yellow cuff light stays off This will calibrate the dinamap press Y and ENTER on DELL CSA keyboard Ready to take blood pressure Press Y and ENTER on the 486 computer keyboard COMPUTER ANKLE Ready to take blood pressure Press A on the IBM keyboard Received command to take manual bp When yellow cuff light stays off This will calibrate the dinamap press Y and ENTER on DELL CSA aia o Ca EUN a keyboard Ready to take blood pressure e ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 43 Press A and ENTER on the IBM keyboard IBM Computer Monitor Received command to take manual bp This will calibrate the dinamap 486 Computer Monitor COMPUTER ANKLE Press A on the IBM keyboard Ready to take blood pressure When yellow cuff light stays off e Received command to take ankle bp presa Y and ENTER on PUES keyboard i After the data has been collected a copy of the data sent to the IBM will be copied onto the IBM monitor The data displayed will look something like this IBM Computer Monitor Received command to take manual bp This will calibrate the dinamap outer Monitor COMPUTER ANKLE Press A on the IBM keyboard Ready to take blood pressure When
6. DISTENSIBILITY TRACKING Ready toi take blood pressure TRACK LEFT SIDE Received command to take arm S EXIT OR SKIP DISTENSIBILITY i B 12 33 50 BBA13053400130533093082132068 ii M d Use the arr w key to highlight EXIT OR SKIP in yellow and press ENTER to advance the program and wipe gel from the participant s neck Ihe messages on the computer screen will prompt the sonographer to execute sitting and standing blood pressures as described in Section 7 5 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 64 8 3 21 e Once the automatic blood pressure is finished the participant is thanked for their cooperation and escorted from the room ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 65 8 3 22 The sonographer presses Y and ENTER on the 486 keyboard The 486 screen will now read 486 Computer Monitor pe IA IBM Computer Monitor A second standing bp will taken in twenty Press E to Exit on IBM seconds When you see the C on the IBM ede to take blood pressure Press Y and ENTER on the DELL CSA A 12 33 50 28413053400130533093082132068 Press E to exit the bp program Press E on the IBM keyboard The IBM blood pressure program is automatically exited The program creates a file containing the recorded blood pressures which is placed in the study s directory The file is named with the participant ID as the file name and b
7. Proximal Common Carotid Artery 34 Aouenbal Time id Combination of Internal and External Carot Doppler tracing Figure 17 Flow Patterns Procedure ion Biosound Screen Calibrat Figure 18 t 3 VERSION 3 0 01 95 isi Ultrasound Scanning Procedures V ARIC PROTOCOL 6a Right Side Left Side Common Optimal Angle o E Ana j Bifurcation Far Wall Bifurcation Near Wall Figure 19 Image As Seen On Biosound Monitor Proper Cursor Placement ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 35 36 7 PARTICIPANT PRELIMINARIES The participant will have been asked to refrain from smoking vigorous exercise and drinking coffee tea and soft drinks containing caffeine during the night preceding and the day of the ultrasound examination since these may alter heart rate and or blood pressure 7 1 Participant Orientation to Ultrasound Examination The participant is positioned on the exmination talbe in a supine position The sonographer describes in general terms the examination to be done A suggested statement follows Ultrasound is a new painless and low risk method to examine arteries using sound waves which you cannot hear but which are able to see arteries under your skin Before the ultrasound exam begins a thin gel will be applied to the skin and an instrument will be placed on it This procedure will be used to look at the arteries on both sides of your nec
8. 34 34 35 54 55 66 67 68 69 70 71 72 73 1 INTRODUCTION The ultrasound examination of the ARIC cohort participants consists of the following components i ultrasonic imaging of the carotid arteries in the neck and 2 monitoring of arterial blood pressure throughout the ultrasound examination This protocol details both types of procedures Additional instructions for monitoring arterial blood pressure are detailed in the Dinamap Service Manual which is included with each Dinamap Model 1846SX unit Interpretation of the ultrasound examination performed at the Ultrasound Reading Center URC is described in the Ultrasound Assessment Part 2 Reading Protocol ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 2 2 SELECTION OF ULTRASOUND SYSTEM The ultrasound system selected for use in the ARIC Visit 1 1987 1989 and Visit 2 1990 1992 exams was the Biosound 2000 II Selection of the Biosound 2000 II was based on the results of a series of detailed protocols performed on systems provided by four different manufacturers and included in vitro tests on excised arteries measurement of the transmitted pressure pulse with a miniature hydrophone transducer routine system performance measurements on phantom test objects and in vivo evaluations which included considerations of ease of use by the sonographer The ultrasound system selected for ARIC Visit 3 1993 1995 is the Biosound Phase 2 The Biosound
9. 86 A 1 A 1 A 2 A 5 A 6 A 7 A 10 A 12 A 13 A 15 Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure 1 2 3 4 5 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 21 28 29 MANUAL 6A LIST OF FIGURES Ultrasound Assessment Equipment Sonographers s Box Ultrasound Assessment Equipment Biosound Phase 2 VCR Ultrasound Assessment Equipment Biosound Phase 2 Printer Ultrasound Assessment Equipment DINAMAP Monitor Ultrasound Assessment Equipment Computer PC 486 o Ultrasound Assessment Equipment Tower PC 486 Ultrasound Assessment Equipment Computer IBM XT Ultrasound Assessment Equipment Cabling Connections Reference e 1 o gt e 0 gt e Ld L Phantom Placement o gt 4 gt e e o Cross Section or Transverse View of 6 mm Phantom Target Phantom Filament Images o Schematic of Carotid Artery Segments Interrogated o Common Carotid Artery all four boundaries visualized The BIfUrGBEION ae amp e he As do Ro DR URS A de Doppler Tracing Internal Carotid Art
10. Co PAPER ECG RHYTHM STRIPS E ULTRASOUND VIDEO CASSETTES F BACKUP TAPE CARTRIDGE G PAPER FORMS LIST TYPE MEL T 6 COMMENTS CONCERNING SHIPMENT CONTENTS nn MH ME H M MH M MM M sess pc 7 SENT DATE TIME _ _ _ AM PM 8 INITIALS OP STAFF MEMBER PREPARING SHIPMENT hide RARE Az EIRIAZIALIPLAERIETATALTTETELItLT 9L OCOLcmfIDI6 9 COMMENTS OM CONDITION OF TOTAL SHIPMENT ON ARRIVAL EO ci n rr rr eee 10 ARRIVE DATE __ _ __ TIME _ _ _ AM PM 11 INITIALS OF STAFF MEMBER RECEIVING SHIPMENT __ ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 13 APPENDIX VIII INFORMATION REFERENCE SHEET T List of contact personnel when experiencing equipment or procedure failure during the ultrasound scan Before contacting the individual by phone make a list of the specific problem symptom include the date symptom started and date service was requested Fax this list to your contact person and fax a copy to the URC attention Delilah Cook Chief Reader and Carolyn Bell login Follow up on service by sending a summary of results by computer network mail U S mail or fax preference of the field center to URC 1 Biosound 800 428 7378 Fax 317 841 8616 Phase 2 Unit only Bob Nitch Dave Struewing Mike Meador 2 URC 919 759 2137 Fax 91
11. Retired 5 Electrocardiography 6 Ultrasound Assessment a Ultrasound Scanning Procedures b Ultrasound B mode Image Reading Protocol C Distensibility Scanning Protocol Retired d Distensibility Reading Protocol Retired 7 Blood Collection and Processing 8 Lipid and Lipoprotein Determinations 9 Hemostasis Determinations 10 Clinical Chemistry Determinations Retired 11 Sitting Blood Pressure 12 Quality Assurance and Quality Control 13 bl naiofante Imaging a Magnetic Resonance Imaging Protocol b Magnetic Resonance Imaging Reading Protocol 14 Retinal Photography 15 Echocardiography 10 MANUAL 6A TABLE OF CONTENTS INTRODUCTION e o SELECTION OF ULTRASOUND SYSTEM e e o o ULTRASOUND AREA INSTRUMENTATION a a The Video Cassette Recorder e The Study Flow Program o 3 1 3 2 3 3 3 4 The 486 SX Computer ec do e Ue DD ae 3 5 3 6 IBM XT Computer e 3 7 EQUIPMENT MAINTENANCE 8 8 8 t 8 2 The Biosound Phase 2 Ultrasound Imaging System e e e e e The RMI Tissue Mimicking Ultrasound Phantom lt e e LJ e Ld Dinamap Automated Blood Pressure Apparatus V A A 4 4 1 Biosound Phase 2 Ultrasound Imaging System 4 2 Video Cassette Recorder P 4 3 RMI 414 B Tissue Mimicking Ultrasound 4 4 486 SX Computer
12. since it is important that all participants be treated the same way 7 5 3 Blood Pressure Examination Instructions to position the cuff and to take manual ankle pressure will appear on the ultrasound computer monitor The computer monitors will display the following messages 486 DELL CSA Monitor MANUAL ANKLE blood pressure no Ready to take blood pressure Press M on the IBM keyboard When yellow cuff light stays off press Y and ENTER on DELL CSA keyboard Press M on the IBM keyboard If an adequate systolic blood pressure measurement is not obtained at the ankle the sonographer verifies that the cuff has been wrapped appropriately and has not slipped If upon inflation the cuff rolls down toward the foot the cuff should be reapplied more snugly If the cuff unwraps upon inflation a larger cuff may be substituted If a cuff is rewrapped or changed an additional manually triggered BP is taken ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 42 IM 486 Computer Monitor MANUAL ANKLE blood pressure IBM Computer Monitor Ready to take blood pressure Press M on the IBM keyboard Received command to take manual bp This will calibrate the dinamap When yellow cuff light stays off press Y and ENTER on DELL CSA keyboard After the manual blood pressure is taken the screens will read IBM Computer Monitor Ready to take blood pressure
13. 0 01 95 61 Press Y and ENTER on the 486 computer keyboard The 486 screen will now read 486 Computer Monitor y RM IBM Computer Monitor 8 12 33 50 BBA13053400130833093082132068 DO PRELIMINARY SCAN NOW E Ready to take blood pressure PRESS NEXT SITE WHEN DONE Ready Ko ala blood pressure 8 2 24 The sonographer now enters comments on log sheet for reference later when computer comments will be required Please note that the VCR will continue in RECORD mode 8 3 Left Carotid Scan 8 3 1 The head and neck are positioned for the exam of the left carotid The foam rubber wedge is placed on the participant s right side and the head is rotated toward the foam rubber pillow as outlined in the introduction of this section 8 3 2 Do Preliminary Scan now press next site when done message appears on monitor 8 3 3 A transverse scan of the common carotid artery is first performed with the patient head position and transducer interrogation angle as shown in Figures 26 29 Using fine transducer angulations to clearly display the blood intima boundaries within the vessel the transducer is slowly moved toward the mandible until the widening of the carotid bulb and finally the internal and external carotid arteries are visualized Using the knowledge of the relative orientation of the internal and external carotids from this scan the optimal angle which should best display the tip of the flow divider may be determined
14. 098 ee med 329 00 ntt e e SETE onus O Cauna Es peu Pn g E 4 pos amp ery dd TO BP CUFF Figure 4 Ultrasound Assessment Equipment DINAMAP Monitor ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 15 Computer PC 486 Facing Rear Panel Inputs from Inputs from Computer REN Sonographer s Box Video Hi Red line upward 2 y u gt 1 O La Inputs from Phase II Red line on left Inputs from Computer Keyboard Inputs from Dinamap Data Interface Figure 5 Ultrasound Assessment Equipment Computer PC 486 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 TOWER COMPUTER PC 486 FACING REAR PANEL m am p A DAA we A ee eee ee ee ee ee ee eee e ES e tee E TER AC POWEN I 99 2 SE Y UD se m a i i SCHON SN gt MONITOR 7 ARI E A eL Pry nt pan rnou FROM DINAMAP 3 MOBOUND RED LINE ON LEFT NOT URED NOT URED COUPUIFA MONITOR CAME FROM SONOROX 82 REO LINE ON MONI fnou ANC BOY AED LUNG ON RIGHT Figure 6 Ultrasound Assessment Equipment Tower PC 486 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 17 Vent notysed to other computer notused power cable keyboard monitor cable Dinamap cable Figure 7 Ultrasound Assessment Equipment Computer IBM XT ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VE
15. Biosound Phase 2 must be in the LUT LN mode Check for the LUT LN setting on the third line of the right Phase 2 monitor If the LUT LN is not present press the blue IMAGE PROCESS key and select LINEAR This will be displayed in the upper right portion of the screen Press the first menu key located on the Phase 2 keyboard to make selection for LUT LN After acquiring LUT LN press the ESCAPE key NOTE Menu keys are the five black keys located at the top of the Phase 2 keyboard Check the image orientation It must be in standard mode At the main menu press the Image control option then press the TGC option Last press the Standard option Once these steps are completed return to the main menu by pressing Escape until the main menu appears ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 TO a b d 23 enter participant information on the tape menu screen do the following Press the 4th menu key to display the Setup menu Press the first menu key to display Patient menu Press the first menu key again Name becomes highlighted Type in participant s last name followed by first and middle initials Press the ESCAPE key or the RETURN key Press the second menu key for Participant ID information Type in the field center identification code followed by the participant s ID number Example F123456 Press the ESCAPE key or the RETURN key to return to the Patient menu When finish
16. ENTER key If the date is incorrect type the correct date and press the ENTER key After pressing the ENTER key the time appears Verify or correct it as instructed above and press the ENTER key After pressing the ENTER key ARIC STUDY appears very quickly followed by the VERSION screen Press the ENTER key The computer screen will read MOUNT TAPE AND MOUNT DISK B DRIVE ENTER WHEN READY The ENTER key is pressed after completing each field on the screen When the sonographer enters information on the screen he she may move back to make corrections by using the arrow keys on the keyboard 7 4 Preliminary Questionnaire The operator completes the questionnaire as follows The 486 computer screen will read PUT TAPE IN THE PHASE 2 VCR and PUT 3 1 2 DISK IN DRIVE B Follow the instructions placing a sVHS videotape cassette in the VCR and a previously formatted 3 1 2 diskette Press the ENTER key After pressing the ENTER key a WAIT message appears while the Phase 2 is setting up to record on the tape Wait until the Demographic screen appears One by one the field requiring information to be supplied by the sonographer will be highlighted in yellow For example when the Patient ID is yellow the sonographer would then type in the participant s ID number followed by the ENTER key Note that the field center first character is inserted automatically If the ID s do not match the sonographer should determine which compute
17. Phase 2 is the updated model of the Biosound 2000 II It was chosen because the older model is no longer manufactured and maintenance of a high performance level in the 2000 II would be increasingly difficult to achieve during this Visit The Phase 2 performs essentially the same as the Biosound 2000 II The improvements include a lighter transducer probe an extended deeper field of view improved gray scale presentation and a closer adherence to the NTSC standards for video signals ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 3 ULTRASOUND AREA INSTRUMENTATION The ultrasound area instrumentation consists of a Biosound Phase 2 ultrasound imaging system an NEC PC 1 2 Video Cassette Recorder an RMI 414B Tissue Mimicking Ultrasound Phantom a 486 SX computer an IBM XT computer a Dinamap automated blood pressure machine and a computer software study flow program The equipment was designed and selected to assist the sonographer in adhering to the protocol steps Figures are presented at the end of Section 4 including a Cabling Connections Reference A brief description of each piece of equipment follows 3 1 The Biosound Phase 2 Ultrasound Imaging System The Biosound Phase 2 system is a high resolution ultrasound imaging system designed for relatively shallow anatomical structures such as the extracranial carotid arterial system Images of the arteries are obtained using a nominal 8 MHz transducer driv
18. The second phase approximately 80 hours at the Ultrasound Reading Center consists of lectures demonstrations and practical laboratory experience on the following topics a Overview of the Study b Role of the Ultrasound Reading Center c Ultrasonic Physics I including basic physics concepts units of measurement and mathematics arising in the medical applications of ultrasound d Overview of atherosclerosis and a detailed discussion of the normal artery wall e Ultrasonic Physics 2 including a discussion of the properties of ultrasonic waves reflection at boundaries and scattering from small objects f Ultrasonic Physics III including the Doppler effect ultrasound transducers and sound beams g Pathology of Atherosclerosis h Principles of Ultrasonic Instrumentation including pulse echo imaging Systems pulsed Doppler systems and spectral analysis i Basic operation of the Biosound Phase 2 j Instrument Performance Monitoring k Basic Operation of the Custom Study Equipment l Principles of Ultrasound Arterial Scanning The remaining training time at least 15 hours at the field center will be Spent practicing scanning technique on volunteers with the protocol including the use of the study flow program and personal computer The field center coordinator and the chief sonographer need to help the novice sonographers in their recruitment and provide scheduled time for at least one volunteer practice scan
19. Ultrasound Imaging System Each field center is required to have Biosound representatives perform a preventive maintenance check four times a year and to send copies of all Biosound reports to the Ultrasound Reading Center More frequent service visits may be required if any problems occur between scheduled preventative maintenance visits The air filter on the Biosound Phase 2 is removed and cleaned monthly This helps to encourage air flow to keep the equipment cool and operating more reliably The transducer head is to be examined for air bubbles daily before scanning is attempted Follow Biosound procedures to remove air bubbles 4 2 Video Cassette Recorder The Video Cassette Recorder should be cleaned every six months by a Biosound technician during one of their preventive maintenance visits to the field center 4 3 RMI 414 B Tissue Mimicking Ultrasound Phantom The RMI 414B phantom is checked weekly to be sure all seals are tight and that the tissue mimicking gel inside has not dried out Proper care and maintenance of the test phantom is described in the instruction manual accompanying the phantom The phantoms are stored in an airtight resealable plastic container A few drops of water or a wet sponge should be added to this container before sealing to minimize desiccation of the tissue mimicking material Phantom specifications are found in the phantom instruction manual 4 3 1 Ultrasound Equipment Performance Check An
20. and 6 2 3 and shown in Figure 19 The sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape When the sonographer is ready to image the LEFT BIFURCATION he she presses NEXT SITE footswitch or NEXT SITE on the sonographer box to advance the program to the next site The transducer is moved distally to the bifurcation area The cursor is placed at the tip of the flow divider Section 6 3 3 The sonographer optimizes the arterial interfaces at this site and angle The computer monitor indicates LEFT BIFURCATION The sonographer optimizes the arterial interfaces at this site and when the best possible image is obtained as outlined in Sections 6 1 and 6 2 4 presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape When the sonographer is ready to image the LEFT INTERNAL CAROTID he she presses NEXT SITE footswitch or NEXT SITE on the sonographer box to advance the program to the next site The sonographer moves the transducer distally to the proximal centimeter of the internal carotid artery The computer monitor indicates LEFT INTERNAL CAROTID The cursor is placed into the correct position to indicate the tip of the flow divider as discussed in Section 6 3 4 The sonographer optimizes the far wall arterial interfaces and when the best possible image is obtained as outlined in Sections 6 2 2 and 6 2 5
21. blanket is replaced to make the participant comfortable as the blood pressure procedures move to the arm 7 5 2 Applying the Blood Pressure Cuff to the Arm Proper size of the cuff is essential for accurate blood pressure measurement Field Centers have four standardized cuffs available small adult adult large adult and thigh cuff The same standardized cuff sizes are used for sitting blood pressure and for the measurement of postural changes in Ultrasound blood pressure Use the cuff size used for the sitting blood pressure measurements recorded on the Itinerary Form for selecting the size of the Dinamap cuff for the upper extremity The standard cuffs provided are by the Baum Company for the sitting blood pressure and by Dinamap for the blood pressure measurements at the Ultrasound work station ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 40 Once the participant is given instructions and explanations and the equipment has been checked blood pressure measurement begins The following steps must be followed precisely l If the participant indicates that there is a medical or post surgical reason for not having the blood pressure measured on the right arm or if the right arm is missing proceed with the left arm Indicate on the Itinerary Form and on a Note Log that the left arm is used If in doubt or if the participant prefers not to have a blood pressure taken on either arm the sono
22. center of the lumen The optimum ultrasound image appears between the lower and upper imaging lines For the left side the tip of the flow divider is placed on the upper imaging line The crosshair is placed on the upper imaging line approximately in the center of the lumen The optimum ultrasound image appears between the upper and lower imaging lines ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 30 Internal External Landmarks Segment 4 Tip of Flow Divider Bifurcation Segment Origin of Bifurcation 4 is Common Carotid Segment Figure 12 Schematic of Carotid Artery Segments Interrogated ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 31 Right Common Carotid Artery UTO n hr a L Lay Pim r tp pr m su wan 2 an a i gt NO AD ta k CERA i had du e di t s D 4 ae n 4 We LT 1 hu Be lees ETAT LUI fF 1 Qe e J u m B hr tos Pa En pe au Ted Y y y n m 1 MEL ts et ME ams inns e m t et n tu MI IHE 1 m te si 1 j ml i i tine mar m LJ M M Ina i ul pe ens x LI il NH a A w a z 4 i L a 8 a a Y F h att eni x h Aen g L ello II a atts madly A Ma A ape Lr ed ma il te meas ate L E i BL at ppi ams Uhu i n ET v m TEM 4 ne
23. is pressed The sonographer observes the tracing on the left monitor and listens to the Doppler signal by turning up the audio on the instrument panel If the ultrasound transducer is in the internal carotid artery the flow pattern will be that of a low resistance bed This signal has a rapid upstroke and a quasi steady flow through systole and diastole The flow continues throughout the cardiac cycle and begins to increase again at the next systole Flow directed toward the head and away from the heart throughout the cycle is represented as a tracing above the baseline in Figure 15 If the Doppler signal does not correspond to the expected pattern the cursor is placed within the other branch of the common carotid artery The external carotid artery is usually nearer the skin surface when viewed from an anterior angle and is a high resistance vessel The characteristics of Doppler signal in this vessel are a forward flow with a sharp upstroke and sometimes a high resistance artery is cessation of flow before the onset of the next systole as defined in Figure 16 A Doppler signal for a combination of internal and external carotid flow patterns is illustrated in Figure 17 The extent to which the Doppler effect occurs depends upon the relative orientation of the direction of blood flow and the direction of propagation of the ultrasound pulse If the two directions are parallel the effect is maximum If the directions are perpendicular in princ
24. o 4 5 IBM XT o o 4 6 Dinamap Automated Blood Pressure DAILY PRELIMINARIES y 4 sss s 5 1 Equipment e s 0 e v 5 2 Biosound Phase 2 setup 5 3 SU DDIIeSg de LO A a ous e e o Phantom ARTERIAL SITES AND ANATOMIC STRUCTURES TO BE EXAMINED 6 1 Priority for Boundary Visualization 6 2 The Carotid Arteries gt 6 3 Cursor Placement by Site and Side PARTICIPANT PRELIMINARIES 4 4 a e 7 1 Participant Orientation to Ultrasound 7 2 Participant Apparel o dud Study Preliminaries 7 4 Preliminary Questionnaire 7 5 Blood Pressure e e ee o o 7 6 CAROTID SCANS o gt o gt Calibration 4 43 4 0 4 49 de SE ee A Right Carotid Scan i ed gt 99 Left Carotid Scan 2 e Question Screens o Ultrasound Conclusion co 00 Co 00 e oh WN n Preparation for Ultrasound Examination Examination ONOGRAPHER TRAINING CERTIFICATION AND MONITORING S 9 1 Training sa we os Us 9 2 CertificaLlOon i gw di X amp A Oe 9 3 Monitoring 4 39 we 3 Bi ee 9 4 The B Mode Study Scan Evaluation Form 9 5 The Lead Study Sonographer SUMMARY OF CHIEF SONOGRAPHER DUTIES e gt e e e e o ps N UU amp Y
25. on the upper imaging line The ultrasound transducer is manipulated until the far or near wall image is optimized The crosshair is then moved to a position along the upper imaging line near the wall interfaces being imaged The crosshair should not interfere with the wall interfaces being imaged but remain in the lumen area For the left side the tip of the flow divider is placed on the lower imaging line The crosshair is placed at the tip of the flow divider on the lower imaging line The optimum ultrasound image appears between the lower and the upper imaging lines In the two views of the bifurcation when only the left far wall or near wall is imaged the tip of the flow divider is placed on the lower imaging line The ultrasound transducer is manipulated until the far or near wall image is optimized The crosshair is then moved to a position along the lower imaging line near the wall interfaces being imaged The crosshair should not interfere with the wall interfaces being imaged but should remain in the lumen area ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 29 6 3 4 Internal Carotid Crosshair Placement The landmark for the internal carotid artery is the tip of the flow divider Primarily the far wall of the internal carotid is imaged For the right side the tip of the flow divider is placed on the lower imaging line The crosshair is placed on the lower imaging line approximately in the
26. ongoing quality assurance check of Biosound instruments is performed twice a month at each field center This is accomplished by a scan of identical RMI Tissue Mimicking Phantoms The scans are sent to the Ultrasound Reading Center for evaluation and consist of one scan of a 6 mm diameter simulated vessel within the phantom and one scan of a set of filaments within the phantom The following instrument performance protocol is done by a certified sonographer at each field center on the second and fourth Wednesdays after the Biosound ultrasound system has been permitted to warm up for at least 30 minutes In addition the procedure is always repeated after the following a After a manufacturer s service call is performed on the Biosound instrument b After the transducer is repaired or replaced A log is maintained to insure these tests are performed per the above schedule ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 The scan of identical phantoms at each field center provides data for an ongoing quality assurance program to monitor the performance of each Biosound instrument Through this program uniform standards are maintained throughout the project The RMI 414B ultrasound phantom is placed upright on the examination table with the LONG side of the rectangular case parallel to the longer side of the table The end of the phantom containing the filaments ranging from 0 5 to 4 0 cm should be positione
27. per day The chief sonographer determines when the new sonographer has attained sufficient skills to produce a scan according to this protocol This portion of training is done under the direct supervision of the chief sonographer who guides evaluates offers suggestions for improvements and answers questions as they arise 9 1 3 Stage 3 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 79 When the chief sonographer determines the new sonographer is ready the new sonographer scans volunteers with minimum supervision from the chief sonographer When the chief sonographer has reviewed 5 practice scans that comply with the standards of quality of interfaces image alignment cursor placement interrogation angles and overall quality of scanning and the new sonographer has demonstrated that she can perform a scan which conforms to protocol within the time allotted by her field center for an ultrasound scan the chief sonographer notifies the Ultrasound Reading Center that the sonographer has completed the practice phase 9 1 4 Stage 4 After completion of the practice phase the new sonographer performs no more than two scans per day on adult volunteers At least ten scans are performed in this mode All such studies are identified and sent to the URC for evaluation along with the normal weekly shipment of tapes The scans subject to this evaluation are scans for which the ultrasound equipment is working properly an
28. presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape When the sonographer is ready to image the LEFT BIFURCATION FAR WALL he she presses NEXT SITE footswitch or NEXT SITE on the sonographer box to advance the program to the next site The computer monitor indicates the LEFT BIFURCATION FAR WALL OPTIMAL ANGLE The transducer is moved back to the bifurcation area to obtain an image of the bifurcation at the optimal angle The cursor is placed at the tip of the flow divider Section 6 3 3 The transducer is slowly tilted along the arterial axis So that the far wall of the bifurcation becomes vertical in the center of the display screen The sonographer optimizes the intima media interfaces on the far wall During this maneuver the near wall echoes will deteriorate When the far wall interface echoes are optimized as outlined in Section 6 2 6 1 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 63 the sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 3 16 When the sonographer is ready to image the LEFT BIFURCATION NEAR i WALL he she presses NEXT SITE footswitch or NEXT SITE on the sonographer box to advance the program to the next site 8 3 17 The computer monitor indicates the LEFT BIFURCATION NEAR WALL OPTIMAL ANGLE The transducer is slowly tilted along the art
29. purposes in the ultrasound area The computer interacts with the sonographer and ultrasound area equipment to perform the following tasks a TO obtain participant data such as identification number birth date race and gender b To establish files for participant data with appropriate names and file extensions C TO keep a record of the study steps performed including quality assurance studies from the study flow program d To determine the frequency of quality assurance studies and the arterial sites where the quality assurance studies are performed e To record data on hard disk for temporary storage and on diskette to send to the Ultrasound Reading Center The sonographer interacts with the computer during the initial questionnaire and at the completion of the study The study flow program interfaces with the IBM XT to control the Dinamap blood pressure monitor and to control the VCR operation Instructions on the computer screen from the study flow program determine when to take blood pressures manually At other times blood pressures are taken automatically by the Dinamap under computer control The computer controls the PC VCR video cassette recorder The primary purpose of the PC VCR is to record the B scan video images for reading at the Ultrasound Reading Center however it performs additional tasks It records audio comments of the sonographers as the scan progresses for the ultrasound readers to aid them in the inter
30. review the scanning protocol with the chief sonographer o The chief sonographer will observe the sonographer perform that part of the scan which was found not to conform to standards e The sonographer will discuss with the chief sonographer ways to improve visualization at the specific site s The sonographer will report back to the URC on the steps taken to effect the improvement e The sonographer will continue to scan o The URC will continue to monitor levels of visualization 9 2 8 Non conforming moderate The sonographer chief sonographer and study coordinator will receive written notification of the sonographer s scanning performance The chief sonographer will check equipment performance and preventive maintenance record e The sonographer will review the scanning protocol with the chief sonographer The sonographer will review training materials on the principles of physics and anatomy o The chief sonographer will observe the sonographer perform that part of the scan which was found not to conform to standards The lead study sonographer will identify patterns which might reveal the reason for failing to conform to the standard document ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 78 areas in need of improvement and communicate her findings to the sonographer e The sonographer and chief sonographer will discuss ways to improve visualization at the specific
31. should also be labeled accordingly At the end of each week the cassette is shipped to the Ultrasound Reading Center with the current shipment of B mode tapes A second tape is used to record the next week s scan s and a third tape for the week after These three tapes will be rotated until they are full Completed tapes will be stored at the Ultrasound Reading Center and another tape will be started at the field center when this occurs 4 3 2 Additional Points to Remember While scanning the phantoms the sonographer is to look for changes in the following e shape of simulated vessels these should appear circular e the gain settings required to obtain adequate images or e the focal settings required to obtain images If the sonographer notices changes in any of these conditions he she should do the following e Contact the Biosound technician authorized to work with this instrument Bob Nitsch 800 428 7378 and e Contact the Ultrasound Coordinator at the Ultrasound Reading Center at 910 759 2137 and report the action to be taken by the Biosound technician Note Other Biosound personnel should not work on the instrument unless specifically authorized by Mr Nitsch If the phantom surface begins to cave in or pucker e Call the supplier to arrange service e Notify the Ultrasound Reading Center Coordinator immediately Following any service call the chief sonographer is to send a copy of the service report to the URC Coord
32. the participant that sitting and standing blood pressures will now be taken The sonographer should instruct the participant to rest quietly during these blood pressures and assist the participant to these positions with as little movement as possible Following these guidelines the sonographer then asks the participant to sit ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 50 Press S on the IBM keyboard The IBM screen will read IBM Computer Monitor Ready to take blood pressure Received command to take arm bp B 12 33 50 BBA13053400130533093082132068 oz 3 x S Ready to take blood pressure press Y and ENTER on Dell CSA cercare gt dta Received command to take sitting bp after 30 sec The IBM computer will automatically wait the 30 seconds required before taking seated blood pressure as required in the protocol After the data has been collected a copy of the data sent to the IBM will be copied onto the IBM monitor The data displayed will look something like this ui IBM Computer Monitor Ready to take blood pressure Received command to take sitting bp after 30 sec S 12 33 50 BBA13053400130533093082132068 After the seated blood pressure is taken and the cuff is fully deflated the IBM screen wili read p IBM Computer Monitor Ready to take blood pressure Received command to take sitting bp after 30 sec S 12 33 50 BBA13053400130533093082132068 dre Y and ENTE
33. using the diagrams in Figures 26 29 The entire length of each carotid system is now scanned longitudinally at this optimal interrogation angle to provide an overall qualitative impression of the extent and severity of disease and the quality of the image at this interrogation angle Unusual anatomic features or possible lesions are observed Oral comments are recorded during the exploratory scan to assist the reader during the reading process 8 3 4 The cursor is placed in the Doppler mode on the Biosound instrument panel The sonographer determines which artery is the internal carotid artery The cursor is first moved into one branch and then the other The Doppler key is depressed in order to view the Doppler spectra on the Biosound screen The key is depressed again to stop the Doppler This is repeated in each branch The internal carotid artery is identified based on the criteria outlined in Section 6 2 5 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 62 8 3 5 8 3 9 8 3 10 8 3 11 8 3 12 8 3 13 8 3 14 8 3 15 The sonographer verifies that the computer monitor indicates the LEFT COMMON OPTIMAL is to be scanned The ultrasound transducer is moved proximally to view the distal centimeter of the common carotid artery The cursor is placed in the lumen Section 6 3 2 The best possible image of the left common carotid artery in the optimal angle is obtained as outlined in Sections 6 1
34. will now display the first scanning screen which looks like this 486 Computer Monitor M i IBM Computer Monitor RECORD TO START Ready to take blood pressure Start Code Calibration a WA n dE Received command to take arm bp Right Common Optimal B 12 55 so BBA130S3400130533093082132068 Right Bulb Optimal Right Internal EN En Right Bulb Far Right Bulb Near The 486 computer is now ready for the standard procedure for a B mode ultrasound scan of the right side Instructions for scanning the right side are discussed in Section 8 2 After the right scan which may or may not include QCs has been completed the computer monitors will read 486 Computer Monitor Lai 1 Cc puter Monitor COMPUTER ARM Ready to take blood pressure Press B on the IBM keyboard Received command to take arm n bp put To CONTINUE B 12 dos 50 BBA130S3400130533093082132068 press Y and ENTER on DELL CSA SERO to take neces pressure keyboard ci Press B on the IBM keyboard ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 48 486 Computer Monitor COMPUTER ARM IBM Computer Monitor Received command to take arm bp Press B on the IBM keyboard B 12 33 50 BBA13053400130533093082132068 To CONTINUE Ready to take blood pressure press Y and ENTER on DELL CSA keyboard Received command to take arm bp After the data has bee
35. written and given to them n case special test equipment or boards are required f Responsible for communication with the Ultrasound Reading Center g Responsible for sonographer recertification as outlined in Section 9 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 82 11 LABELING AND MAILING TO THE ULTRASOUND READING CENTER 11 1 Labeling of Video Cassettes and Diskettes Video cassette and diskette labels identify the field center and are numbered sequentially The starting number for each field center is listed below Forsyth ARIC FHS F10001X F20001X Jackson ARIC J30001X Minneapolis ARIC FHS M50001X Framingham FHS B60001X Salt Lake City FHS U80001X Hagerstown ARIC W70001X The final character shown as an X here is a code check character Each field center maintains a log that records the video cassette number and the participant identification numbers on that cassette Log sheet reference Appendix 5 The information in columns 1 10 must be included and filled out by sonographers before they send it to the Ultrasound Reading Center 11 1 41 Each video cassette is labeled with the video cassette number and no more than four participant identification numbers Note that the video cassette number appears only once on the short edge of the video cassette The video cassette box is also labeled on the short edge See labeling diagram Appendix 6 11 1 2 Each diskette is labeled with t
36. 9 759 2139 Peripheal Equipment Sonographer box attached foot switches and cables ultrasound software the arterial tracker and transducer arm at centers where applicable Sonographer certification and training and data flow Kathy Joyce Administrative Secretary who will direct call as follows Delilah Cook Protocol procedure Sonographer Training and Data Flow or equipment problems Carolyn Bell Login and Distensibility Pam Wells or Delilah Cook Sonographer Certification and Review J Dell Computers Damian Brown 800 284 1200 ext 3967 or local compouter repair facility 4 Dinamap Johnson amp Johnson Critikon Pam Thornbury 800 255 2500 or 919 852 2733 5 Oscilloscope Tektronix 700 Professional Drive Gathersburg Maryland 20879 6 Strip Chart Recorder MFE Instruments John Lepore 800 472 4633 Fax 508 921 9110 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 14 II Miscellaneous Equipment Information 1 Dinamap calibration and alarm settings are Pre set at the factory and do not need any action from the sonographer factory settings are acceptable for our purpose 2 S VHS tape Do not purchase Sony brand tapes because the NEC VCR is very sensitive and does not operate properly with this brand Due to storage limitation at the URC the Fuji tape has been tested and is recommended for this study ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSI
37. Atherosclerosis Risk in Communities Study Protocol Manual 6a Ultrasound Assessment Scanning Procedures Visit 3 Version 3 0 January 1995 For Copies Please Contact ARIC Coordinating Center Department of Biostatistics CSCC University of North Carolina at Chapel Hill CB 8030 Suite 203 NationsBank Plaza Chapel Hill NC 27514 FOREWORD This manual entitled Ultrasound Assessment Scanning Procedures is one of a series of protocols and manuals of operation for the Atherosclerosis Risk in Communities ARIC Study The complexity of the ARIC Study requires that a sizeable number of procedures be described thus this rather extensive list of materials has been organized into the set of manuals listed below Manual 1 provides the background organization and general objectives of the ARIC Study Manuals 2 and 3 describe the operation of the Cohort and Surveillance Components of the study Detailed Manuals of Operation for specific procedures including those of reading centers and central laboratories make up Manuals 4 through 11 and 13 through 15 Manual 12 on Quality Assurance contains a general description of the study s approach to quality assurance as well as the details for quality control for the different study procedures ARIC Study Protocols and Manuals of Operation MANUAL TITLE 1 General Description and Study Management 2 Cohort Component Procedures 3 Cohort and Community Surveillance 4 Pulmonary Function Assessment
38. N FAR WALL OPTIMAL ANGLE The transducer is moved back to the bifurcation area to obtain an image of the bifurcation at the optimal angle The cursor is placed at the tip of the flow divider Section 6 3 3 The transducer is slowly tilted along the arterial axis so that the far wall of the bifurcation becomes vertical in the center of the display screen The sonographer optimizes the intima media interfaces on the far wall During this maneuver the near wall echoes will deteriorate When the far wall interface echoes are optimized as outlined in Section 6 2 6 1 the sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 59 8 2 17 When the sonographer is ready to image the RIGHT BIFURCATION NEAR WALL he she presses the NEXT SITE footswitch or presses the NEXT SITE switch on the sonographer box to advance the program to the next site 8 2 18 The computer monitor should indicate the RIGHT BIFURCATION NEAR WALL OPTIMAL ANGLE The transducer is slowly tilted along the arterial axis back towards the optimal angle and then beyond so that the near wall of the bifurcation becomes vertical in the center of the display screen The cursor is placed at the tip of the flow divider Section 6 3 3 The sonographer optimizes the media intima interfaces on the near wall During this maneuver the far wal
39. ON 3 0 01 95 71 LEFT SIDE EXTERNAL INTERNAL SKIN B MODE IMAGE ROTATE LONGITUDINAL Figure 27 Left Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 72 LEFT SIDE INTERNA A j E i i E t Aga x E aus d SKIN EXTERNAL B MODE IMAGE LONGITUDINAL Figure 28 Left C rotid Artery Transv rse Scan Investigation Procedure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 13 LEFT SIDE INTERMAL SKIN EE m EXTERMAL B MODE IMAGE ROTATE TRANSOUCER HEAD 90 EE Figure 29 Left Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 74 9 SONOGRAPHER TRAINING CERTIFICATION AND MONITORING 9 1 Training The sonographer training program includes training sessions held at the respective field centers and the Ultrasound Reading Center followed by practice scans at the respective field centers and certification steps at the field centers 9 1 1 Stage 1 During the initial weeks a new sonographer works with the certified sonographers at the field center to observe the ultrasound area activities become familiar with the equipment read the introductory material supplied by the URC and become familiar with this scanning protocol 9 1 2 Stage 2
40. ON 3 0 01 95 A 15 APPENDIX IX READING LIST The Language of Anatomy From Gardner W D amp Osburn W A 1973 Structure of the Human Body 2nd ed Philadelphia W B Saunders Company Angiology From Williams P L and Warwick R eds 1980 Gray s Anatomy 36th ed Philadelphia W B Saunders Co Blood Supply to the Head and Neck From Fried L A 1976 Anatomy of the Head Neck Face and Jaws Philadelphia Lea amp Febiger Systemic and Pulmonary Circulations Froms Underhill S L Woods S L Sivarajan E S and Halpenny C J eds 1982 Cardiac Nursing Philadelphia J B Lippincott Co Pathogenesis of Atherosclerosis From Cardiac Nursing The Carotid Plaque From Robicsek F Ed 1986 Extracranial Cerebrovascular Disease Diagnosis and Management NY McMillan Publishing Diagnostic Ultrasound Principles Instruments and Exercises by Frederick W Kremkau Ph D Third Edition Publisher W B Saunders Company Harcourt Brace Jovanovich Inc Chapter 1 from Diagnostic Ultrasound Frederick W Kremkau Ph D 3rd edition Chapter 2 pages 9 30 in Diagnostic Ultrasound Chapter 2 pages 41 45 of Diagnostic Ultrasound Chapter 3 of Diagnostic Ultrasound Chapter 4 pages 105 114 and pages 130 137 of Diagnostic Ultrasound How a B Mode lungs formed A Summary Chapter 5 in Diagnostic Ultrasound Article Artifacts in Ultrasound Imaging Kremkau amp Taylor Chapter 6 in Diagno
41. Press any key message on the Phase 2 keyboard and wait of the Phase 2 at the bottom of displays the main menu The menu displays finish the boot up procedure appears on the screen press the letter Dp for Main Menu to appear on the right monitor screen If any key other than D is pressed the unit is put into a time out mode For study purposes a time out mode is not appropriate Therefore the operator should press D This will put the unit in a continuous mode of operation Check the VCR display screen for VCR setting Check the channel display for setting L If the L is not displayed press the up and down arrow keys on the VCR keyboard labeled Channel until it does appear ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 22 The VCR settings should be as follows Panel Settings Record Level L 5 R at least 5 or more adjust to sonographer preference not to exceed Red level on scale display Remote Control ON 1 same as Remote 2 R C Setting Tape Remain T120 Edit off Line IN VIDEO S VHS ON Keyboard Settings TV CATV AIR displayed to the right of counter Stereo L R Normal L R Displayed under audio scale Select PROBE 1 located on the Biosound Phase 2 keyboard The probe must warm up for 30 minutes The Phase 2 boot up procedure is now complete In order to obtain the highest quality images for this equipment the Biosound manual directs that the
42. Press the first menu key again for Distance plus the cursor will appear in the upper portion of the screen d Move the cursor to the vertical center position identified by the doppler cursor and make certain it is kept in the vertical center when it is moved during the performance check The transducer power is activated and the system is placed in the normal B scan imaging mode The transducer focus setting is placed in the 3 0 cm focus position Far focus e Adjust video gain to 50 and adjust TGC settings for optimal imaging The sonographer enters the RECORD mode by turning off the pause switch on the NEC PC VCR and scans the phantom Throughout the scan exert only minimal pressure on the phantom surface with the transducer To obtain the images in this procedure the long imension of the white transducer plate is parallel to the long dimension of th phantom The sonographer obtains a cross sectional view of the most superficially 2 cm depth located simulated vessels and then positions the larger 6 mm diameter of the three vessels in the vertical center of the screen as confirmed by the cursor position Toggle the Doppler cursor OFF The crosshair should be contained well within the outline of the vessel insuring that it does not obscure the reflections from the near or far walls Figure 10 When a satisfactory image is seen on the screen mark this point on the tape for the Ultrasound Reading Center The sonographer moves t
43. R on Dell CSA Ready to take blood pressure do reus Lu ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 51 Press Y and ENTER on the 486 computer keyboard The 486 screen will now read l 486 Computer Monitor um Co puter Monitor First STANDING Ready to yake blood pressure pressure ji Received command to take sitting bp after 30 sec Press T on the IBM keyboard S 12 33 50 85213053400130533093082132068 When yellow cuff light stays off press Y and ENTER on Dell CSA keyboard The sonographer asks the participant to stand Press T on the IBM keyboard The screen on the IBM will now read see Computer Monitor X IBM Computer Monitor sE Received command to take sitting bp after 30 sec S 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure att Y and ENTER on Del1 CSA Received command to take first standing bp after 30 R ybeard S v nl sec ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 52 The IBM computer will automatically wait the 30 seconds required before taking the first standing blood pressure a s required in the protocol After the data has been collected a copy of the data sent to the IBM will be copied onto the IBM monitor The data displayed will look something like this j IBM Computer Monitor S 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Received command to take first standing bp af
44. ROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 APPENDIX III TROUBLESHOOTING Phase 2 Setup The instructions on the Phase 2 right monitor suggests that any key can be pressed to display the main menu However if the letter D is not pressed at that point the Phase 2 cannot be placed in debug mode without first shutting down all of the equipment If shutdown is necessary follow instructions in Section 6 to startup the equipment If the PROBE 2 key is pressed a No Probe message appears Press the PROBE 1 key to continue If a wrong menu key is pressed press the ESCAPE key located on the Phase 2 keyboard to return to the previous menu At any time during the setup it is discovered that the participant s name or I D is incorrect press the ESCAPE key until the main menu screen returns Press the 4th menu key to display Setup Press the first menu key for Patient menu Press the first or second menu key to correct the patient information Once in the Name or Participant I D menu the CLEAR key located on the Phase 2 keyboard can be used to clear an incorrect entry Remember that the DOP CURSOR key is used as a toggle It can remove or return the cursor at any given time If the Doppler doesn t work well check cursor alignment with blood flow see Appendix I and the focus setting It should be aligned to the cursor artery Check for Bubbles in transducer Focus and bubbles in the transducer greatly affe
45. RSION 3 0 01 95 18 CABLING CONNECTIONS REFERENCE VIR LEFT AUDIO OUT WITH A V LEFT AUDIO IN VTR RIGHT AUDIO WITH _ A V RIGHT AUDIO OUT IN VTR RIGHT AUDIO IN WITH A V RIGHT AUDIO OUT VTR VIDEO OUT WITH A V VIDEO IN VTR VIDEO IN WITH A V VIDEO OUT NEC VCR POWER WITH POWER SUPPLY CONNECTION NEC VCR A N NIDEO PRINTER WITH PRINTER V O IN NUMBER 8A WITH NUMBER 8B AC LINE WITH VIDEO PRINTER Figure 8 Ultrasound Assessment Equipment Cabling Connections Reference ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 19 Phantom Placement Figure 9 t 3 VERSION 3 0 01 95 isi ARIC PROTOCOL 6a Ultrasound Scanning Procedures V 20 Cross Section or Transverse View of 6 mm Phantom Target Figure 10 Phantom Filament Images Figure 11 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 5 DAILY PRELIMINARIES 5 1 Equipment 21 The equipment in the ultrasound area is turned on and warmed up for a minimum of 30 minutes before any studies the following order 1 Biosound Phase 2 2 NEC VCR 3 Dinamap 4 Arterial Wall Tracker 9 Strip Chart Recorder 6 Oscilloscope 7 IBM XT Computer 8 486 Computer 5 2 Biosound Phase 2 setup begin The equipment is to be turned on in As the unit powers up the two monitors on the unit will begin to set up their menus The monitor on the right instructions for the operator to When the
46. TICIPANT NUMBER LABELS HENE ON tHE CASE ATTACH ALL LABELS TO FACE IN SAME DINECTION CASSETTE LABEL 4 TOP PLACE CASSETTE amp PARTICIPANT LABELS HENE PARTICIPANTS IN SAME ORDEN AS ON CASSETTE BOTTOM GOES INTO DISK DRIVE THIS SIDE UP 3 1 2 INCH DISK LABELING ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 10 APPENDIX VI VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM THIS END GOES INTO CASE FINST Super VHS SVHS WHEN PUT INTO PLACE CASSETTE AND ei PARTICIPANT NUMBER SIDE or LABELS HERE CASE Boso Kenia GETS LABEL ON TIIE CASE ATTACH ALL LABELS TO FACE IN SAME DIRECTION CASSETTE LABEL PLACE CASSETTE amp PARTICIPANT LABELS HERE PARTICIPANTS IN SAME ORDER AS ON CASSETTE BOTTOM GOES 4 INTO DISK DRIVE THIS SIDE UP 3 1 2 INCH DISK LABELING ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 11 FUSI cassere HIS ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 12 APPENDIX VII WEEKLY SHIPPING LOG WEEKLY SHIPPING LOG SHIPPING LOG Le SHIPPING NUMBER 2 NAHE OF SHIPPER 3 SHIPPING TO 4 REPORTING PERIOD STARTING DATE mm dd yy ENDING DATE _ _ __ mm dd yy S NUMBER OF ITEMS TYPE OF ITEM NUMBER SENT NUMBER RECELVED A DATA DISKETTES B 12 LEAD ECG PAPER TRACINGS
47. Y Ow woOo000 ps 21 21 23 24 24 24 27 36 36 36 36 37 38 46 56 56 57 61 65 65 74 74 75 79 80 80 81 ii 11 12 13 14 LABELING AND MAILING TO THE ULTRASOUND READING CENTER 11 1 Labeling of Video Cassettes and Diskettes 0 0 0 0 0 11 2 Content of Mailing 0 0 1 0 11 3 Frequency of Mailing 11 4 Package Labeling 4 4 s se on 11 5 Verification of Mailing Contents e POLICIES PROCEDURES FOR REPORTING B MODE ULTRASOUND RESULTS 12 1 Routine Reporting e 9 00 0 9 0 0 9 0 0 00 0 9 0 0 12 2 Procedures for Non routine Results gt e PARTICIPANT SAFETY PRECAUTIONS e e APRENDICES La s 4 4 ve ne n 09 a a a a APPENDIX I DOPPLER SIGNAL ID OF THE INTERNAL CAROTID ARTERY APPENDIX II SOFTWARE TROUBLESHOOTING gt e e o APPENDIX III TROUBLESHOOTING se e s s s o o o o o APPENDIX IV BIOSOUND KEYBOARD s o APPENDIX V LOG SHEET REFERENCE e ooo APPENDIX VI VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM APPENDIX VII WEEKLY SHIPPING LOG o APPENDIX VIII INFORMATION REFERENCE SHEET e APPENDIX IX READING LIST e s o o o oo 82 82 82 82 83 83 i 84 84 i 84
48. a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 3 6 IBM XT Computer The IBM XT computer is used to initiate the Dinamap for blood pressure measurements All measurement results are stored on the IBM XT until the ultrasound exam is over The results are stored on a 5 1 4 floppy disk That floppy is inserted into the A drive on the 486 computer and transferred to a 3 1 2 floppy for transfer to the Ultrasound Reading Center 3 7 Dinamap Automated Blood Pressure Apparatus A series of blood pressure measurements is made during the ultrasound examination The purposes are to provide baseline supine seated and standing blood pressure measurements and to estimate an ankle arm index Blood pressure is measured using the Dinamap Model 1846 SX an automated oscillometric device The Dinamap Operation Manual should be read carefully before performing the blood pressure measurements The timing of blood pressure measurements and the sequencing of the Dinamap Model 1846 SX are determined by the IBM XT The Dinamap Service manual is included with each machine at the time of purchase If that manual is lost another can be ordered from the Dinamap zone office ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 6 4 EQUIPMENT MAINTENANCE Equipment maintenance is performed periodically Detailed records of maintenance are to be kept at each field center by the chief sonographer 4 1 Biosound Phase 2
49. a nonexistent number of a month or day is entered for example 14 12 32 or 12 32 32 an ERROR message appears Press the ENTER key and type in the correct date of birth Note If an incorrect date of birth that is a valid date is entered the sonographer is responsible for correcting it at the verification screen Note The backspace key can be used to make corrections until the ENTER key is pressed Note If you are at the end of the demographics screen and notice an incorrect entry use the left arrow key to toggle back to make the necessary corrections Common Problems Associated With the Scanning Screen If the NEXT SITE footswitch is pressed instead of the SELECT footswitch for a particular site the program will toggle forward You can immediately correct for this by pressing the PREVIOUS SITE on the sonographer s box to toggle back to the skipped site and then tone the image using the SELECT foot switch Accidently pressing the SELECT instead of NEXT SITE before pressing RECORD on the sonographer s box will cause the computer monitor to blink for 5 seconds The study flow screen will return after the blinking stops The screen will read Press RECORD on the sonographer s box A WAIT message appears while the VCR is automatically put into record by the computer Software appears to be Hung When the software will not respond to the input commands the scan can be continued by following these steps 1 fast forward the t
50. ad in a standard way The wedge is placed on the examination table with largest surface of the wedge facing down It is placed on the examination table next to the side of the neck to be evaluated in such a way that the 90 angle is furthest from the midline of the face This positions the 45 angle closest to midline The wedge is then gently pushed toward the midline of the head until the 45 angle edge touches the scalp The participant is then asked to rotate his head toward the foam rubber wedge until the side of the head just above the ear rests against it The chin may be raised slightly and the shoulder adjusted slightly for better visualization The ultrasound equipment is positioned so that the sonographer has access to the participant s neck all instrument controls and foot pedals 8 1 Calibration A calibration is done before each scan The following settings must be followed in order to standardize the calibration procedure The Phase 2 settings should be as follows o the gain is set at 50 e the TGC is in a stair step alignment the focus is in the mid focus setting 2cm The transducer motor is on and there should not be any gel on the transducer The monitor displays will read as follows _____ 486 Computer Monitor O IBM 4 Computer Monitor ipee TO START Ready to take blood pressure Code Calibration Received command to take arm v bp Common Optimal de 12 33 50 BBA13053400130533093082132068 B
51. ameter than the external 2 the blood flow velocity pattern in the two vessels as determined with Doppler ultrasound ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 26 is distinctly different Used together these two considerations permit the internal carotid artery to be identified with a h gh degree of confidence During the preliminary scanning procedure it is necessary to distinguish clearly between internal and external carotid arteries Although tributaries originating from the external carotid artery may occasionally be viewed with B mode ultrasound to help in this differentiation Doppler ultrasound in most cases is more efficient and specific for this separation The method and criteria for this identification are as follows A B mode image is obtained of the carotid bifurcation where the common carotid artery divides In some instances the best anatomical angle will show the flow divider as well as the proximal internal and external carotid arteries In the remaining cases the flow divider and only one vessel can be seen from a single angle In those instances the other artery can be visualized by gently rocking the ultrasound probe back and forth in angle or position or both Doppler is used to differentiate internal and external carotid arteries in these instances To obtain a Doppler sample of each artery the Doppler sample volume is placed into the branch farthest from skin surface The sonographer
52. ape to the end of recorded space 2 press RECORD on the VCR key pad 3 verbally identify the SELECT and NEXT SITE segments on the tape 4 Note on logsheet for this tape to be re striped 5 Record answers to questions that would normally be on the US screens Lesion Sonographer impression Distensibility Code Deviations in Protocol i e B mode BP and Distensibility Wait Screens If the wait screen seems hung it has a time out feature after 2 minutes the software will issue the command to retry the procedure A Rewind for 8 seconds and ENTER message appears when the VCR and computer have lost the address and does not know what section of the tape it is at Sometimes this step will have to be repeated more than once Be ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 sure the rewind 8 seconds starts with recorded space on the tape The counter will count backwards when rewinding in a recorded space Pause amp Record mode on VCR If VCR is in the PAUSE amp RECORD mode and does not release to RECORD only press the PAUSE key on the VCR key pad to release it manually The program will then proceed through the flow of the scanning program The VCR will then go into RECORD and you can continue with the scan Comment Screen a ars hung If the screen is blank with no COMMENTS heading the sonographer should enter the comments and press ENTER to continue through the program To Check Head
53. ct both Doppler and Distensibility To ensure that the image orientation is in standard mode the following should be completed daily Select Image Control Options Select TGC Select Standard Press ESCAPE to exit out to Main Menu In the event that the equipment still fails to operate as designed call the Biosound technician for assistance ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 BIOSOUND KEYBOARD IV APPENDIX T MM B gt nuni M 411 H berrea fare fants 41 11 Te flan 41 1111 4 III E ttt 1 Ul 1411 41 nuit qipi 1000000 T 411 iN Li Hb TS nnt 41 Un ng 41 III ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 APPENDIX V A B c D E F H r 45 4K 4L M LOG SHEET REFERENCE For field center use to record evaluation record notices from the URC Place cassette ID label here Participant ID Participant date of birth Participant s last name first initial then middle initial Record actual scan date mm dd yy _ VCR start time VCR stop time only needs to be recorded when the last participant on the tape is scanned Sonographer ID Sonographer Impression P Poor F Fair G Good E Excellent List QC site scanned List tracking impression If no tracking is done list reason Yes No List sites not completed
54. d closest to the head of the table Figure 9 The top surface of the phantom is cleaned with a damp cloth or paper towel to remove residue The water tray on the top of the phantom is half filled with tap water to permit efficient coupling of the ultrasound transducer to the tissue equivalent medium DO NOT USE GEL AS THE COUPLING MEDIUM Minimal pressure is exerted on the phantom surface with the transducer throughout the Scan Excessive pressure or gel on the phantom surface can cause severe damage to the phantom A two minute segment of B mode phantom images is recorded during this check as described below Use a separate sVHS video tape to record only phantom images Selected frames are read at the Ultrasound Reading Center to quantitatively document the ultrasound system imaging characteristics Set the VCR display screen to be sure the channel display is set at L If the L is not displayed press the up and down arrow keys on the VCR keyboard labeled Channel until it does appear Press the letter D on the Phase 2 keyboard and wait for Main Menu to appear on the bottom of the right monitor screen of the Phase 2 Select PROBE 1 located on the Phase 2 keyboard Make sure the LUT LN setting is on the third line of the right Phase 2 monitor If the LUT LN is not present press the blue IMAGE PROCESS key and select LINEAR LUT LN will be displayed in the upper right portion of the Screen Note The Menu keys are the fiv
55. d external carotid arteries are visualized Using the knowledge of the relative orientation of the internal and external carotids from this scan the optimal angle which should best display the tip of the flow divider may be determined using the diagrams in Figures 22 25 The entire length of each carotid system is now scanned longitudinally at this optimal interrogation angle to provide an overall qualitative impression of the extent and severity of disease and the quality of the image at this interrogation angle Unusual anatomic features or possible lesions are observed Oral comments are recorded during the exploratory scan to assist the reader during the reading process 8 2 4 The cursor is placed in the Doppler mode on the Biosound instrument panel The sonographer determines which artery is the internal carotid artery The cursor is first moved into one branch and then the other The Doppler key is depressed in order to view the Doppler spectra on the Biosound screen The Doppler key is pressed again to stop the doppler mode until the sonographer is ready to view the Doppler spectra again This is repeated in each branch The internal carotid artery is identified based on the criteria outlined in Section 6 2 5 Press the DOP CUR key to remove the Doppler cursor from screen The preliminary scan is complete 8 2 5 To put the crosshair cursor on the tape for landmark identification do the following a Press the third menu key to display
56. d study participants have arteries and anatomy which permit the walls to be adequately visualized These scans will be evaluated by the lead study sonographer or his her designee for effective adherence to protocol During this stage feedback on this process will be given to the trainee When ten scans have conformed to the study standards the sonographer will be certified to scan participants in this study and have the data resulting from those scans entered into the study database 9 2 Certification 9 2 1 Certification of Experienced Sonographers A sonographer attains certification to scan based upon her ability while following the ARIC FHS scanning protocol to visualize arterial walls consistent with the process average of all sonographers certified in Visits one and two of ARIC as indicated by paired points marked by certified readers at the Ultrasound Reading Center The monthly review of the scan by the lead sonographer and chief sonographer must on average meet scanning standards As long as a sonographer maintains visualization consistent with the process average of her peers and the average of monthly review scans meet protocol Standards she retains certification ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 76 9 2 2 Certification of New Sonographers When the novice sonographer has successfully met all training requirements as outlined in Section 9 1 written notification is sent to him h
57. ds for participant studies and are part of an ongoing sonographer recertification process The Ultrasound Reading Center readers read the ultrasound images from all the data collection procedures and the quality assurance images Image interpretation results from study mages and quality assurance images from the same site and angle are compared for use in sonographer quality assurance procedures The purpose of this evaluation procedure is to determine the consistency and reproducibility of scanning and of interpreting ultrasound images The results of these evaluations are reported periodically to the ARIC Coordinating Center and the field centers ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 80 9 4 The B Mode Study Scan Evaluation Form The current version of the B mode study scan evaluation form is on file at the Ultrasound Reading Center in Winston Salem NC This form provides a forum for a detailed accounting of the conformance to scanning protocol as described in this document 9 5 The Lead Study Sonographer The Ultrasound Reading Center is responsible for pre certification certification and re certification of sonographers Certifying processes involve the review and evaluation of B mode scans as well as statistical evaluation of sonographer performance The lead study sonographer provides feedback to the sonographer his her chief sonographer and to the Ultrasound Coordinator This feedback to
58. e as shown in Figure 20 or 21 Note that depending on the degree of tapering in this area the cuff corner will be offset from parallel toward the knee Holding the cuff from sliding wrap the other end over the ankle as shown in step III in Figure 20 or 21 again following the contour of the ankle and secure the Velcro fastener Check to be sure that the corners of the cuff extending above the upper edge of the cuff are about equal If one end extends more than the other loosen the Velcro and adjust the wrap ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 39 Next locate the over the artery marker of the cuff and rotate the cuff so that this line is directly over the posterior tibial artery The cuff may be rotated more easily by sliding it toward the malleolus and after alignment the cuff can be made snug by pulling it up toward the calf The cuff should conform closely to the shape of the ankle with the lower edge 1 to 2 1 2 inches above the malleolus The posterior tibial artery is usually palpated as it courses posteriorly to the medial malleolus Even if the posterior tibial pulse is not palpable the posterior tibial artery is used as the location for the marker line on the cuff for the over the artery position Any kinks in the tubing are removed and tension on the tubing on the participant s leg is relieved If needed masking tape or hospital clips are applied at this time to anchor the tubing
59. e black keys located at the top of the Phase 2 keyboard Check the image orientation It must be in standard mode At the main menu press the Image control option then press the TGC option Last press the Standard option Once these steps are completed return to the main menu by pressing Escape until the main menu appears To enter phantom information on the tape menu screen do the following a Press the fourth menu key to display the Setup menu b Press the first menu key to display Patient menu Press the first menu key again NAME becomes highlighted Type in the phantom serial number and the transducer serial number separated by a space Press the RETURN key C Press second menu key for Participant ID information Type in the field center location and sonographer ID number Press the RETURN key to return to the Patient menu When all entries have been made press the ESCAPE key twice to reach the Main Menu ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 8 The Doppler cursor can be removed by pressing the green DOP CURSOR key located on the Phase 2 keyboard This key may be toggled ON or OFF Place Doppler cursor in the middle section of the screen To put the crosshair on the image to define the vertical center of the screen for landmark identification do the following a Press the third menu key to display the Calculate menu b Press the first menu key to display Distance menu c
60. e conclusion of the examination the sonographer copies the blood pressures files onto a floppy diskette along with the other participant files and sends the diskette along with the videotape to the Ultrasound Reading Center 7 6 Preparation for Ultrasound Examination The subject is in a supine position with his her legs resting comfortably on a pillow The participant s position should allow head rotation to either side The sonographer is seated at the end of the exam table that is nearer the participant s head The top of the participant s head is about one to three inches from the end of the exam table so as to afford easy access to the sonographer of the areas of the neck to be scanned When the 486 computer screen reads Insert Tape and Diskette and Press ENTER when ready Insert tape and diskette and press ENTER The 486 computer screen will read Press Record Press RECORD on Sonographer Box The NEC PC VCR is automatically placed in the RECORD mode by the computer A red circle on the VCR front panel indicates that this VCR is recording A study code flow screen will appear on the 486 monitor The text will be color coded as follows Yellow highlight indicates that a code is to be scanned e Pink highlight indicates that a code is to be scanned next ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 47 e Green highlight indicates that a code has been scanned The 486 computer screen
61. ed press the ESCAPE key twice to reach the main Menu The Doppler cursor can be removed by pressing the green DOP CURSOR key located on the Phase 2 keyboard This key may be toggled ON or OFF The Phase 2 is now set up for scanning 5 3 Supplies The supplies to be used for each day are checked This includes the following a Video cassettes sVHS cassettes for the NEC PC VCR b 3 1 2 diskette for each for each video cassette Ci Participant ID Labels Identification labels are applied to the video cassettes and the diskettes used to store participant information d Aquasonic gel e Paper wipes f 5 1 4 diskette for each video cassette to be used with IBM XT ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 24 6 ARTERIAL SITES AND ANATOMIC STRUCTURES TO BE EXAMINED Ultrasonic imaging methods are used to obtain a non invasive quantitative measure of early atherosclerotic disease The carotid arteries which are the principal suppliers of blood to the brain are a common location for early disease primarily within or in close proximity to the bifurcation These arteries generally located within a few centimeters of the skin surface are well suited to examination with high resolution ultrasonic imaging methods The ultrasound examination concentrates around the segment in the right and left carotid artery known as the carotid bifurcation See Figure 12 Ultrasound examination is attempted a
62. en by a motor in a sector scan format The sector scan format is presented in a rectilinear format with a nominal lateral view of 2 cm and a depth of 5 cm In addition to the B mode image Doppler signals from the arteries can be obtained processed and displayed in a frequency versus time format The Doppler information is used primarily for arterial identification An 1 2 sVHS video cassette recorder VCR is connected to the Biosound Phase 2 The VCR records the ultrasound video information coming from the video channel onto the video cassette 3 2 The Video Cassette Recorder The video recorder is an NEC 1 2 sVHS PC VCR It was chosen to provide Superior image quality cassettes The sVHS cassettes are sent to the Ultrasound Reading Center for interpretation 3 3 The RMI Tissue Mimicking Ultrasound Phantom A modified RMI 414B tissue mimicking ultrasound phantom with water trough attachment is used periodically for performance checks on the Biosound Phase 2 The phantom has arterial mimicking targets of various diameters and depths These targets can be scanned from both longitudinal and transverse directions and the images and video information can be evaluated to assess system performance The images are recorded on 1 2 sVHS video cassettes and sent to the Ultrasound Reading Center ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 4 3 4 The 486 SX Computer The 486 SX computer is used for multiple
63. er File TO change directory to ARIC at the C type cd space ARIC ENTER At C ARIC gt type space header and 2 four digit s will be displayed The first four digits are the tape number and should match the tape being used or if a new tape is to be used the should be one less than the new tape number If the tape number matches the tape being used no edit is needed At the C ARIC gt type cd space ENTER to return to the root directory Begin new scan If the tape number does not match the tape being used do the following At the C ARIC gt type edit space header ENTER A menu driven program will display the file Use the arrow keys to move the cursor to the tape number Insert the correct number and delete the old number by using the delete key When changes are completed press Alt key F key to get the file menu Press X to exit A gray menu box will appear and ask if the changes are to be saved Press Y and ENTER This will return you to the C ARIC gt Type cd space ENTER Begin new scan Select light is on at the beginning of a scan If the Select light is on at the beginning of a scan it must be reset before that scan can be performed To reset the select light At the C gt type cd space test ENTER At C TEST gt type initff ENTER This will cause the select light to go off Then at C TEST gt type cd space lt ENTER gt to return to the root directory of the computer ARIC P
64. er and to the chief sonographer at his her field center informing the new sonographer of his her new status as a certified sonographer 9 2 3 Guest Sonographers During the course of this Study it is expected that upon occasion a sonographer will be unavailable to scan participants without being able to give sufficient prior notice to allow for a reschedule of the participant s visit If no provision were made for such an eventuality participant s would be unduly inconvenienced or may refuse to return to undergo an ultrasound evaluation In such a case in order to prevent a loss of valuable data the services of a guest sonographer may be used A guest sonographer is one who is well versed in the applied principles of carotid ultrasound and who is familiar with the ARIC FHS ultrasound scanning protocol and study equipment The names and qualifications of guest sonographers are to be registered with the Ultrasound Reading Center where they will be assigned ID numbers Prior to substituting for a certified sonographer for this Study the guest sonographer is to re read the protocol and review it with the chief sonographer or in her absence another ARIC FHS certified sonographer Tapes containing scans recorded by the guest sonographer are to be clearly marked to that effect Likewise a notation is to be made on the log sheet Upon receipt of these tapes at the Ultrasound Reading Center these tapes will not be logged in with the tapes pr
65. erial axis back toward the optimal angle and then beyond so that the near wall of the bifurcation becomes vertical in the center of the display screen The cursor is placed at the tip of the flow divider Section 6 3 3 The sonographer optimizes the media intima interfaces on the near wall as outlined in Section 6 2 6 2 During this maneuver the far wall echoes will deteriorate When the near wall interface echoes are optimized the SELECT footswitch is pressed and the image is held in view for at least five consecutive cardiac cycles marking the site on video tape The sonographer removes the transducer from the neck 8 3 18 The sonographer looks at the PC to see if a site will be repeated on the left side for quality assurance purposes QC site If no QC site scan is required on the left side the sonographer presses the NEXT SITE footswitch 8 3 19 If a QC site scan is required the monitor displays in red the QC site and the flow screen highlights the code The sonographer obtains an image of the QC site and angle moves the cursor to the appropriate landmark and optimizes the arterial interfaces When the best possible image has been obtained he she presses the SELECT footswitch and holds the image for at least five cardiac Cycles marking the site on video tape 8 3 20 The NEXT SITE footswitch is pressed twice to advance the program to the option screen for distensibility which will appear as follows 486 Computer Monitor ISEE
66. ery e Doppler Tracing External Carotid Artery e gt Doppler tracing Combination of Internal and External Carotid e 091 0 e e e e 0 e 9 e 9 s e Biosound Screen Calibration Procedure o Image As Seen On Biosound Monitor Proper Cursor Placement Blood Pressure Cuff Placement Left Ankle o Blood Pressure Cuff Placement Right Ankle m Right Carotid Artery Transverse Scan Investigation Procedure od we de Ee we ae I9 29s 4 We Et RC USA VIG 1 Right Carotid Artery Transverse Scan Investigation Procedure e e e 9 9 Right Carotid Artery Transverse Scan Investigation Procedure u 9 Right Carotid Artery Transverse Scan Investigation Procedure e e 0 0 0 Left Carotid Artery Transverse Scan Investigation Procedure e Ue 4 9 o dw v Left Carotid Artery Transverse Scan PEOOOGUPG 4 x oL ce de de he ea Left Carotid Artery Transverse Scan PEOCGUdUFQG s s Wo LE ae We a de Se RD DEO ee eR Rd Left Carotid Artery Transverse Scan Investigation Procedure o o o e Investigation gt e Investigation 11 12 13 14 15 16 17 18 19 20 20 30 31 32 33 33
67. features of the participant This dependence of interrogation angle on the individual participant requires that great care be given during the preliminary examination to identify this angle It depends upon both the ultrasound transducer position and the orientation of the head of the participant If the proximal segments of the internal and external carotid arteries lie in a common plane it should be possible to interrogate the bifurcation from an angle which provides an image characterized by a Y appearance This is illustrated in Figure 14 From this angle the location of the two anatomical references the tip of the flow divider and the initial common carotid widening into the bifurcation can be seen In some individuals it is often difficult to sharply define the origin of the bifurcation if a pronounced widening does not occur but it is most likely to be visible from this angle If the proximal segments of the internal and external carotid arteries do not lie in a common plane it may be impossible for the sonographer to obtain the characteristic Y appearance at the bifurcation Either one or the other of the branches can be imaged at a given interrogation angle but not both In many cases repositioning of the head of the participant see Sections 8 1 and 8 2 may permit the two arteries to more closely approach a common plane Often careful attention to this position and small participant head angle changes will permit the Y to be v
68. grapher should consult with their immediate supervisor 25 If the arm circumference has not been measured at the Sitting Blood Pressure station have the participant stand facing away from the observer with the right arm bent 90 degrees at the elbow hand on midsection Locate the tip of the acromion at the top outer edge of the shoulder blade and measure the length of the upper arm from acromion to tip of elbow using a centimeter tape measure Mark the midway point of the arm and then have the participant relax the arm at the side Wrap the tape around the arm over the midpoint mark making sure that the tape is level Measure the arm circumference to the nearest 1 2 centimeter and record See Table 1 below The range markings on commercial cuffs overlap from size to size and do not offer a precise guideline In the ARIC Study arm size is measured and the cuff size is selected as follows ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 41 Table 1 Determination of cuff size based on arm circumference Cuff Size Arm Circumference Small Adult 24 cm Adult 24 to 32 cm Large Adult 33 to 41 cm Thigh 41 cm The ultrasound part of the exam begins Before activating the next phase of the study take a minute to instruct the participant on the no conversation rule Also remind the participant to hold questions about exam results until after the last portion of the ultrasound station exam is completed
69. he diskette number which is identical to the video cassette number and the participant identification numbers The diskette is placed with its matching video cassette for shipping See labeling diagram Appendix 6 11 2 Content of Mailing Each weekly mailing from the field centers to the Ultrasound Reading Center contains a Video cassettes for the participant ultrasound studies completed the previous week b Diskettes containing the participant files for the ultrasound studies completed the previous week C Diskettes containing the blood pressure files for the ultrasound studies completed the previous week C A copy of the week s log sheet See Appendix 5 e A copy of the Shipping Log sheet for the week f A video cassette containing phantom scan s if appropriate g Biosound Service Report if appropriate 11 3 Frequency of Mailing The video cassettes diskettes and lists described in Section 11 1 are mailed each week no later than Tuesday afternoon to the Ultrasound Reading Center The Ultrasound Reading Center needs to receive these cassettes no later than Wednesday afternoon ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 83 11 4 Package Labeling The address label from each field center has the following information a Field center personnel sending the package b Field center return address Ci The shipping number from the Shipping Log sheet d Address label to
70. he transducer toward the head of the table in order to view the set of filaments ranging from 0 5 to 4 0 cm These are also viewed in cross section making certain the transducer focus setting is in the 3 0 cm position Using the crosshair as a guide the filaments are lined up so that they are centered horizontally across the center of the screen Figure 11 The cursor is positioned in the middle of the screen taking care to avoid obscuring any of the filament reflections The reflections of the deeper filaments will have gaps in them due to shadowing caused by the filaments superficial to them Figure 11 Those gaps are used as an aid in lining up the filaments properly When a satisfactory image is seen the select footswitch to mark this image This concludes the weekly instrument performance test on the RMI phantom The water is carefully removed from the phantom and the phantom is returned to its storage location in the manner described in Section 4 3 Each phantom tape is labeled according to the following format PHANTOM F 93 O3 12 001 F the field center code 93 the year the tape is started 09 the month the tape is started 12 the month the tape is complete left blank until tape is full 001 sequential number of each tape begins with 001 at each field center ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 This label should be placed on the video cassette The video cassette box
71. hich case the external and internal carotid arteries can be defined by the external being more anterior to the internal anatomically If flow is sampled from the common carotid artery there will be a rapid systolic up stroke with small reversal of flow and a quasi steady flow throughout diastole This is a combination of internal and external carotid flow patterns as shown in Figure 17 Because of the more varied positioning and geometry of the internal carotid the sequence of priorities to be used when imaging this segment is modified from that used in the common and bifurcation The two far wall boundaries should receive highest priority the near wall adventitia media interface next priority and finally the near wall intima blood boundary 6 2 6 Independent Views of the Far and Near Bifurcation Walls ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 27 6 2 6 1 Far wall After imaging the far wall of the internal the carotid bifurcation at the optimal angle is imaged again The ultrasound transducer is tilted along the arterial axis in such a manner that the far wall of the bifurcation becomes vertical in the center of the display screen The quality of the near wall echoes will deteriorate At this time small changes in transducer angle are made to image the far wall blood intima and media adventitia interfaces After the far wall image is obtained the transducer is rotated back to obtain the carotid bifurcat
72. inator and or Phantom reader It is important to vary the location of the transducer within the prescribed areas on the phantom when doing the scans i e position in the center left of center right of center in order to extend the life of the phantom 4 4 486 SX Computer In general no maintenance is required on the computer with the exception that if there is one the clock battery is replaced annually In case of any system problems the field center data coordinator contacts the appropriate authorized repair facility 4 5 IBM XT Computer In general no maintenance is required on the computer with the exception that if there is one the clock battery is replaced annually In case of any system problems the field center data coordinator contacts the appropriate authorized repair facility ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 10 4 6 Dinamap Automated Blood Pressure It is recommended that the Dinamap Model 1846 SX be calibrated every six months using calibration procedures in the Dinamap instruction manual Copies of calibration reports are to be forwarded to the Ultrasound Reading Center ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 11 SONOGRAPHER S BOX NEXT SCREEN e SELECT PREV SCREEN FRONT PANEL MEBON CABLE RED UNE ON RIGHT TO NEXT SITE AUDIO TO SELECT FOOTSWITCH OUT FOOTSWITCH REAR PANEL Figure 1 Ultrasound Asses
73. ing the findings of the clinician whether an abnormality was identified and where appropriate to suggest a clinical evaluation 12 3 3 Reporting of Confirmed Alerts by the Field Center to the Participant An examples of a letter to send to the participants in whom a carotid ultrasound alert value is confirmed appear below Alert for lumen narrowing to 2 mm or less As a participant in the ARIC Study you had a B mode ultrasound examination to measure the carotid arteries blood vessels in your neck During that examination narrowing of the of the vessel was found in the artery s Such narrowing is most often associated with atherosclerosis hardening of the arteries While some narrowing is found in many people the amount of narrowing identified on your study was greater than expected residual lumen of 2 mm or less We recommend that you consult with your physician to determine whether further evaluation or treatment is necessary If you do not have a personal physician the ARIC office will be happy to work with you to arrange for a referral ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 86 13 PARTICIPANT SAFETY PRECAUTIONS See Manual 2 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 1 APPENDIX I DOPPLER SIGNAL IDENTIFICATION OF THE INTERNAL CAROTID ARTERY It is important to carefully distinguish between the internal and external carotid arteries using t
74. ing line marked on the Biosound screen passes through the origin of the bifurcation on both near and far arterial walls The crosshair is placed on the upper imaging line approximately in the center of the lumen The optimum ultrasound image appears between the upper and lower imaging lines described in section 6 3 1 For the left common carotid artery the ultrasound transducer is moved so that the lower imaging line passes through the origin of the bifurcation on both near and far arterial walls The crosshair is placed on the lower imaging line approximately in the center of the lumen The optimum ultrasound image appears between the lower and upper imaging lines 6 3 3 Bifurcation Area Crosshair Placement The landmark for all images in the bifurcation area is the tip of the flow divider In some views the tip of the flow divider may disappear but the crosshair should indicate its location on the monitor screen For the right side the tip of the flow divider is placed on the upper imaging line The crosshair is placed on the upper imaging line at the tip of the flow divider The crosshair is placed within the lumen to assure that it will be well clear of all measurement areas The optimum ultrasound image appears between the upper and lower imaging lines In the two views of the bifurcation when only the right far wall or near wall is imaged the tip of the flow divider is placed on the upper imaging line The crosshair is also placed
75. ion optimal angle image again 6 2 6 2 Near wall The transducer is rotated along the axis of the artery so that the near wall of the bifurcation is now oriented vertically in the center of the display screen The quality of the far wall echoes will deteriorate Small changes in transducer angle are made to image the near wall adventitia media and intima blood interfaces 6 3 Cursor Placement by Site and Side 6 3 1 Ultrasound Monitor Horizontal parallel lines should be marked in black on the image screen of the ultrasound B mode im ge monitor These lines serve to delimit the optimal imaging region which is this middle portion of the image area These lines are referred to as the upper and lower imaging lines The two horizontal lines shown on Figure 18 are located where the black lines should be marked on the image screen These lines are to be positioned 3 4 inch inside the top and bottom portion of the active B mode imaging area The crosshair is placed at the level of one of these lines to mark the location of the anatomical landmark for the specific site being imaged The placement of the crosshair is illustrated for all sites in Figure 19 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 28 6 3 2 Common Carotid Crosshair Placement The common carotid artery image is oriented so that the arterial walls appear vertically on the monitor screen The ultrasound transducer is moved so that the upper imag
76. iple NO DOPPLER EFFECT WILL OCCUR While it is impossible get the directions of ultrasound propagation and blood flow exactly parallel they should be as close to parallel as possible in order to obtain a strong Doppler signal Regardless of whether the sidelooking or inline Doppler functions are used the two directions must NOT BE PERPENDICULAR ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 2 APPENDIX II SOFTWARE TROUBLESHOOTING Common Problems and Their Solutions Listed below are some problems you could encounter and some suggestions on how to correct them At the C prompt type aricscan and press the ENTER key The message bad command or file name indicates that an incorrect command was entered Correct the spelling and try again C Date If the correct date appears press the ENTER key If the date displayed is incorrect type in the correct date using the exact format displayed on the computer screen Example 01 14 93 C gt Time If the correct time appears press the ENTER key If the displayed time is incorrect type in the time of day using the exact format displayed on the computer screen Example 10 30 Demographic screen entries Participant ID Six digits must be entered If a digit is left off it must be entered to continue or backspace to correct entire ID Visit Two digits must be entered Example 07 referring to Visit 03 If one digit is entered the computer wait
77. isualized A preliminary transverse scan as described in Section 8 1 3 permits the optimal interrogation angle to be closely approximated even in the more difficult anatomical configurations 6 2 3 The Common Carotid Artery Images of the common carotid artery are obtained at the optimal interrogation angles They are referenced to the origin of the bifurcation where the common carotid begins to widen The segment located 10 mm proximal to this landmark is the focus of attention Both the near wall and far wall interfaces are attempted in this view 6 2 4 The Carotid Bifurcation The segment of the carotid bifurcation extending 10 mm proximal to the tip of the flow divider is imaged at the optimal angle In some participants this may extend into the common carotid The sonographer must place the cursor at the level of the tip of the flow divider Images are then acquired at this interrogation angle taking great care to use the priority sequence of boundary visualization described in Section 6 1 6 2 5 The Internal Carotid Artery The segment of the internal carotid artery far wall extending 10 mm distal from the tip of the flow divider is now imaged at the optimal angle Images are acquired of this segment once again marking the tip of the flow divider as the anatomical landmark It is important to carefully distinguish between the internal and external carotid arteries using two criteria 1 normally the internal has a significantly larger di
78. k During the examination you will hear the noise and feel the vibrations of a small motor that is located within the instrument Occasionally you will also hear the amplified sound of blood flowing through your arteries The equipment will also record my voice as I name the parts of the arteries I scan The complete ultrasound examination should be completed within forty five minutes Since talking or swallowing can cause the arteries to move out of focus and cause this procedure to take longer your cooperation would be appreciated During this discussion the sonographer should remember that the examination to be done is not diagnostic in nature and that all questions asked by the participant that relate to the presence or absence of arter al disease should be referred to the medical director of the Field Center or to his on site representative Information to be given to the participant or his her physician is described in Manual 2 7 2 Participant Apparel The ultrasound component of this examination requires easy access to the skin overlying arteries in the neck Participants wear loose fitting apparel provided by each field center Jewelry present on the head and neck including gold chains necklaces and earrings is removed prior to scanning 7 3 Study Preliminaries 7 3 1 IBM XT Computer The order in which the blood pressure equipment is turned on is critical to the successful functioning of the computer system The Dinamap is fir
79. l echoes will deteriorate When the near wall interface echoes are optimized as outlined in Section 6 2 6 2 the sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape The sonographer removes the transducer from the neck and presses the NEXT SITE footswitch 8 2 19 The sonographer looks at the computer monitor to see if a site will be repeated on the right side for quality assurance purposes QC site If no QC site scan is required on the right side the sonographer presses the NEXT SITE footswitch again 8 2 20 If a QC site scan is required the monitor displays in red the QC site and the flow screen highlights the code The sonographer obtains an image of the QC site and angle moves the cursor to the appropriate landmark and optimizes the arterial interfaces When the best possible image has been obtained he she presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 2 21 The sonographer presses NEXT SITE switches on the sonographer box or on the NEXT SITE footswitch 8 2 22 The gel is wiped from the participant s neck and the head and neck are repositioned for the left side scan 8 2 23 The arm blood pressure screen will appear The sonographer should follow directions on the screen to complete blood pressure measurement 486 Computer Monitor COMPUTER ARM IBM Computer Monitor
80. n collected a copy of the data sent to the IBM will be copied onto the IBM monitor outer Monitor IBM Computer Monitor COMPUTER ARM B 12 33 50 BBA13053400130533093082132068 Press B on the IBM keyboard Ready to take blood pressure To CONTINUE Received command to take arm bp press Y and ENTER on DELL CSA B 12 33 50 BBA13053400130533093082132068 keyboard After the arm blood pressure is taken and the cuff is fully deflated the IBM screen will read a B B 12 33 50 BBA13053400130533093082132068 COMPUTER ARM Press B on the IBM keyboard Ready to take blood pressure To CONTINUE Received command to take arm bp press Y and ENTER on DELL CSA keyboard B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 49 Press Y and ENTER on the 486 computer keyboard The left side menu screen will appear on the 486 monitor and will look like this 486 Computer Monitor J Left Common Optimal Left Bulb Optimal Left Internal Left Bulb Far Left Bulb Near T to take blood pressure After the scan of the left side has been completed The messages on the computer screens will read as follows 486 Computer Monitor a SITTING pressure Press S on the IBM keyboard When yellow cuff light stays off press Y and ENTER on Dell CSA keyboard E DE The sonographer explains to
81. o improve visualization in those sites 9 2 5 Scanning Process Control ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 77 The methods employed by the Ultrasound Reading Center for assuring the quality of ultrasound data are based on the work of F Edwards Demming J M Juran and Ellis Ott Tools include process capability and statistical process control charting techniques with consistent performance and constant improvement as goals Timely feedback is critical to the success of this procedure Therefore on a routine basis based on frequency of scanning and sonographer consistency sonographers will be given detailed reports of their performance and be notified of the extent to which they conform to the quality and quantity of data gathering exhibited by the Study sonographers as a group Below are indicated the steps to be followed based on each sonographer s conformance to these standards 9 2 6 Conforming e The sonographer chief sonographer and study coordinator will receive written notification of her scanning performance The sonographer will continue to scan The URC will continue to monitor levels of visualization 9 2 7 Non conforming slight The sonographer chief sonographer and study coordinator will receive written notification of her scanning performance e The chief sonographer will check equipment performance and preventive maintenance record e The sonographer will
82. o later than the end of the third week of that month It is recommended by the Ultrasound Reading Center that only one review per week be performed to reduce the time commitment during any one week The chief sonographer keeps a log of the review and discusses her findings with the sonographer on a timely basis 9 3 2 Monitoring at the Ultrasound Reading Center Sonographer performance is monitored at the Ultrasound Reading Center using a number of quality assurance procedures The quality assurance procedures include but are not limited to 1 comparing results of repeat studies on a randomly selected identical site and angle of individual participants 2 periodic reports containing statistics of boundary visualization by individual sonographer and study wide 3 visual review of randomly selected participant scans 4 on site monitoring of sonographer performance by designated URC personnel Reports are generated and distributed by the Ultrasound Reading Center In addition the Ultrasound Reading Center can review the same participant Studies reviewed by the chief sonographers at the field centers The sonographer evaluation form is completed at the URC and the results are compared to the chief sonographer s form Any significant differences between evaluations or any significant problems are discussed with the chief sonographers to resolve the differences Results of these sonographer evaluations are used to help maintain high standar
83. o the bifurcation area The cursor is placed at the tip of the flow divider Section 6 3 3 The arterial interfaces are optimized at this site and angle The computer monitor indicates RIGHT BIFURCATION The sonographer optimizes the arterial interfaces at this site and when the best possible image is obtained as outlined in Sections 6 1 and 6 2 4 presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape When the sonographer is ready to image the RIGHT INTERNAL CAROTID he she presses the NEXT SITE footswitch or presses the NEXT SITE switch on the sonographer box to advance the program to the next site The transducer is moved distally to the proximal centimeter of the internal carotid artery The computer monitor indicates RIGHT INTERNAL CAROTID The cursor is placed into the correct position at the tip of the flow divider as discussed in Section 6 3 4 The sonographer optimizes the far wall arterial interfaces When the best possible image as outlined in Sections 6 2 2 and 6 2 5 are obtained the sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape When the sonographer is ready to image the RIGHT BIFURCATION FAR WALL he she presses the NEXT SITE footswitch or presses the NEXT SITE switch on the sonographer box to advance the program to the next site The computer monitor indicates RIGHT BIFURCATIO
84. observes the tracing on the TV monitor and listens to the Doppler signal If the ultrasound probe is in the internal carotid artery the flow pattern will be that of a low resistance bed This signal has a rapid upstroke and a quasi steady flow through systole and diastole The flow continues throughout the cardiac cycle and begins to increase again at the next systole The flow pattern is graphically displayed near the zero baseline Flow directed toward the head and away from the heart throughout the cycle is represented as a tracing above the baseline in Figure 15 If the Doppler signal does not correspond to the expected pattern the cursor is placed within the other branch of the common carotid artery The external carotid artery is usually nearer the skin surface when viewed from an anterior angle and is a high resistance vessel The characteristics of the Doppler signal in this vessel are a forward flow with a sharp upstroke and sometimes a reversal of the flow at diastole multiphasic The hallmark of a high resistance artery is cessation of flow before the onset of the next systole as defined in Figure 16 Abnormal flow is demonstrated by turbulence within the lumen and disruption of normal flow This is identified in the Doppler signal by broadening the Doppler spectrum Severe narrowing of the artery lumen is identified by an increase in the expected peak systolic frequency If occlusion is present there will be no Doppler signal in w
85. oduced by certified sonographers They will first be reviewed by a certified reader If the scans are found to conform to protocol they will be logged in and treated from then on in the standard fashion If however the scans are found not to conform to protocol the Scans will not be logged in and will not be read The field center coordinator chief sonographer and guest sonographer will be informed of the areas where the scan did not conform to the protocol Due to the additional effort required to process these scans no guest sonographer may scan for more than five days or fifteen scans within a two month period without first obtaining special permission from the Executive Committee of this Study Should a field center require additional sonographer support for an extended period guest sonographers must undergo additional training as specified by the Ultrasound Reading Center in order to become certified for this study 9 2 4 Loss of Certification When a sonographer s average monthly boundary visualization falls significantly below the process average for one site by a small amount for a number of sites if the visualization report reveals any trend toward a loss of visualization or if the scans produced deviate from protocol or the average monthly scans reviewed do not meet protocol standards she and her chief sonographer will be notified of the specific nature and extent of loss of consistency so that remedial steps can be taken t
86. onto the IBM monitor The data displayed will look something like this outer Monitor IBM Computer Monitor COMPUTER ARM Received command to take manual bp al AN This will calibrate the dinamap Press B on the IBM keyboard a Ready to take blood pressure TO CONTINUE Li Received command to take arm bp press Y and ENTER on DELL CSA keyboard mE B 12 33 50 BBA13053400130533093082132068 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 46 After the arm blood pressure is taken and the cuff is fully deflated the IBM screen will read id 486 Computer Monitor hs IBM Computer Monitor This will calibrate the dinamap COMPUTER ARM Press B on the IBM keyboard Ready to take blood pressure To CONTINUE Received command to take arm bp press Y and ENTER on DELL CSA keyboard B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Arm blood pressures will be taken intermittently during ultrasound The CSA Dell will prompt the sonographer for BP initiation At the end of the study the program is automatically exited The program creates a file containing the recorded blood pressures which is placed in the studies directory The file is named with the participant ID as the file name and bp as its extension i e X bp where X represents the field center code and the asterisks represent the participant ID number At th
87. ournal of Neuroimaging Vol 1 No 2 May 1991 pages 68 73 High Resolution B Mode Ultrasound Reading Methods in the Atherosclerosis Risk in Communities ARIC Cohort Ward A Riley et al Journal of Neuroimaging Vol 1 No 4 November 1991 pages 168 172 An Approach to the Noninvasive Periodic Assessment of Arterial Elasticity in the Young Riley Barnes and Schey Preventive Medicine 13 169 184 1984 Ultrasonic Measurement of the Elastic Modulus of the Common Carotid Artery The Atherosclerosis Risk in Communities ARIC Study Accepted by Stroke 1992 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95
88. p as its extension i e X bp where X represents the field center code and the asterisks represent the participant ID number 8 3 23 When the Comments screen appears the sonographer types his her comments for the left side images and presses ENTER to advance the program 8 4 Question Screens Following comments is a series of question screens The sonographer uses the ARROW key to select the appropriate answer and presses ENTER to advance to the next screen 8 5 Ultrasound Conclusion Upon completion of the final question screen the program automatically copies all the participant files from the hard drive to the diskette The sonographer applies labels appropriately and fills out the log sheet See Section 11 Copy the blood pressure files onto a 5 1 4 floppy diskette This 5 1 4 floppy and the 3 1 2 floppy containing the participant files should be sent along with the videotape to the Ultrasound Reading Center In addition a 5 1 4 floppy containing a backup copy of the blood pressure files should be stored at the field center ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 66 RIGHT SIDE EXTERNAL SKIN INTERNAL ROTATE TAANSOUCER HEAD 90 Figure 22 Right Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 67 RIGHT SIDE EXTERNAL INTERNAL AU arene
89. pretation of recorded B mode images As the B scan images are being recorded the PC VCR labels the tape with an address on a frame by frame basis The frame address is used at the reader station for frame identification and to compare frame selection among readers A sonographer box transmits signals to the 486 computer These signals initiated either by push buttons or foot switches advance the study flow program through the steps of the scanning program When the sonographer has acquired the best images obtainable at a site the sonographer footswitch is pressed and detected by the computer The frame address on the video tape is read and stored and an audio tone is placed on the audio channel The frame address is later placed in a file for use at the reader station The audio tone identifies portions of the video cassette that the sonographer feels are the best obtainable views of a site and aids readers and or reviewers in finding particular sections on the cassette 3 5 The Study Flow Program The B mode ultrasound examination consists of bilateral carotid artery studies and involves a minimum of 10 steps performed in a similar sequence for each participant A study flow program assists the sonographer during the examination by formatting and displaying computer screens showing steps to be completed and steps which have been completed A manual override box is available for making any changes in the programmed sequence ARIC PROTOCOL 6
90. r shallower wall is visualized An image of the common carotid artery in which all four boundaries are visualized is shown in Figure 13 This sequence of priorities is used when imaging any segment of the carotid arteries with the exception of special views at the bifurcation and the internal carotid These are discussed in Section 6 2 6 2 The Carotid Arteries 6 2 1 Anatomical References The arterial segments defined for ultrasonic examination are referenced to certain anatomical landmarks which are normally identifiable within the carotid system One is the tip of the flow divider which defines the position along the vessel where the internal carotid artery and external carotid artery begin A second but less clearly delineated is the location where the common carotid artery begins to widen into the carotid bifurcation These landmarks are illustrated in Figure 12 In order to image defined segments referenced to these landmarks longitudinal images are required During each image sequence the cursor on the Biosound image screen is placed at the vertical level of the appropriate landmark for use in the reading of the B mode images at the Ultrasound Reading Center ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 25 6 2 2 Optimal Interrogation Angle The optimal ultrasonic interrogation angle which permits clear identification of the anatomical references on the B mode images depends upon specific anatomical
91. r has the wrong ID Then exit the program on that computer and re initiate the program and enter the ID correctly ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 38 Type the Visit Code using two digits and press the ENTER key Type the Sonographer ID using three digits and press the ENTER key Verify the Cassette ID and press the ENTER key The Cassette ID is automatically assigned by the computer program Type participant s initials last name gender race and date of birth pressing the ENTER key after each entry When all fields have been filled in EVERYTHING CORRECT appears on the lower portion of the screen Answer N or Y N signifies that an error was made in the demographic entries Y signifies that everything is correct If the choice made is Y a wait screen appears while the VCR sets up to begin recording Do not press the ENTER key while the WAIT screen is visible If the choice is N the demographics screen appears again and incorrect entries are re typed See above After the last entry VERIFY appears again Type Y if all is correct if not type N and loop through this process once more Information from this questionnaire is entered into the field center computer This information will be sent to the reading center on a diskette under the participant s DEM file 1 5 Blood Pressure 7 5 1 Applying the Blood Pressure Cuff to the Ankle If the date is an even number place the c
92. rapher will make another taped scan of the same initial volunteer Both tapes will be sent to the UC for evaluation e The sonographer will report back to URC on steps she has taken to effect improvement When the URC determines that improvement has been demonstrated with visualization at or above the study average for all sites the sonographer chief sonographer and field center coordinator will be notified and the sonographer may then resume scanning The URC will continue to monitor levels of visualization ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 79 9 3 Monitoring Sonographer performance is monitored throughout the Atherosclerosis Risk in Communities Study at the respective field centers and the Ultrasound Reading Center 9 3 1 Monitoring at Field Center Each month the chief sonographer reviews one scan per sonographer for his her field center The primary purpose for review is to ensure the quality of the gtudy data and adherence to the scanning protocol The B mode images are evaluated for overall image quality the presence and clarity of the arterial wall boundaries and the presence of anatomical landmarks and a cursor indicating the location of an anatomical landmark and the vessel lumen The time of the month for sonographer review for each sonographer is determined by the chief sonographer but is not the same from month to month All reviews are sent to the URC before and n
93. ress Y and ENTER on PELDI CEA Received command to take manual bp keyboard W This will calibrate the dinamap After the manual blood pressure is taken the IBM screen will read 486 Computer Monitor IBM Computer Monitor MANUAL ARM Ready to take blood pressure Press M on the IBM keyboard Received command to take manual bp m This will calibrate the dinamap vien yeliow cuff light stays off du Y and ENTER on DELL CSA Ready to take blood pressure keyboard ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 45 Press Y and ENTER 486 computer keyboard 486 Computer Monitor IBM Computer Monitor COMPUTER ARM Ready to take blood pressure Received command to take manual bp This will calibrate the dinamap Press B on the IBM keyboard To CONTINUE press Y and ENTER on DELL CSA Ready to take blood pressure keyboard Rn PEU po a Press B and ENTER on the IBM keyboard IBM Computer Monitor Ready to take blood pressure outer Monitor lt COMPUTER ARM Press B on the IBM keyboard Received command to take manual bp This will calibrate the dinamap _To CONTINUE ZEE Ready to take blood pressure press Y and ENTER on DELL CSA keyboard Received command to take arm bp Press Y and ENTER on the 486 computer keyboard to continue After the data has been collected a copy of the data sent to the IBM will be copied
94. ressure Received command to take second standing bp After the data has been collected a copy of the data sent to the IBM will be copied on the IBM monitor The data displayed will look something like this zT Computer Monitor E IBM Computer Monitor A SECOND STANDING pressure A second standing bp will taken in twenty won ih taken after 20 seconds seconds Ready to take blood pressure Received command to take second standing bp R 12 33 50 BBA13053400130533093082132068 Press E to exit the bp program ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 54 Left Leg Center lower leg with center of cuff Fabric velcro on outside Fabric velcro Entire cuff rotated medially akr Media malleous Figure 20 Blood Pressure Cuff Placement Left Ankle ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 Center lower leg with center of cuff Fabric velcro on outside Medial malleous 55 Right Leg Fabric velcro Entire c rotate media Figure 21 Blood Pressure Cuff Placement Right Ankle ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 56 8 CAROTID SCANS Orientation of the participant s head as follows The participant is asked to look straight up at the ceiling A triangular shaped firm foam rubber wedge shaped in a 45 45 90 degree form is used to position the he
95. s for the second digit Sonographer Three digits must be entered If two or less digits are entered you will not be able to continue If by accident a fourth digit is pressed an ERROR screen appears Press the ENTER key The demographic screen reappears Corrections can be made at this time by using the backspace key Cassette The identification of the tape will automatically appear on the demographics screen the tape has to be put in before this screen Verify tape in VCR and screen ID s match Initials Enter the participant s first and middle initials If the participant has no middle initial enter the one initial and press ENTER To insert a period for no initial press ENTER again Once the period appears press ENTER again to move to the next field If it is necessary to make a correction use the left arrow key to return to the INITIALS column to make corrections Last Name Type only the first five digits of the participant s last name and press the ENTER key No more than five digits will be recorded on file Gender Enter F or M If a different letter is entered an ERROR message appears Press the ENTER key and type in the correct entry ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 3 Race Enter B W or O If something different is entered an ERROR message appears Press the ENTER key and type in the correct entry Date Of Birth Type in the participant s date of birth If
96. sites The sonographer will practice that part of the scan on volunteers The sonographer will report back to URC on steps taken to effect improvement The sonographer will continue to scan a The URC will continue to monitor levels of visualization 9 2 9 Non conforming severe e The sonographer chief sonographer and study coordinator will receive written notification of the sonographer s scanning performance The sonographer will stop scanning cohort participants immediately The chief sonographer will check equipment performance and preventive maintenance record e The lead study sonographer will identify patterns which might reveal the reason for failing to conform to the standard document areas in need of improvement and communicate her findings to the sonographer e The sonographer will review training materials on the principles Of physics and anatomy The sonographer will review the scan protocol with the chief sonographer The chief sonographer will observe the sonographer as he she performs that part of the scan which was found not to conform to standards e The sonographer and the chief sonographer will d scuss ways to improve visualization at those specific sites e The sonographer will produce a taped scan of a volunteer of cohort age The sonographer will then make practice scans on volunteers When the chief sonographer determines that sufficient improvement has been made the sonog
97. sment Equipment Sonographers s Box ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 12 BIOSOUND PHASE 2 REAR PANEL SHOWING VCR OUTPUT TO COMPUTER CAMERA j CONTROL NEC E VIDEO CASSETTE RECORDER UL LABEL INPUT FROM SONCBOX 3 AUDIO OUT OUTPUT OUTPUT TO TO t gt TRACKER 2 TRACKER y TRIG IN BIOSOUND PHASE 2 REAR PANEL CONNECTIONS Y 41 RF IN RFOUT 1 TAIG MONITOR AUDIO VCR MONITOR REAR AUDIO VIDEC VIDEO iN O Figure 2 Ultrasound Assessment Equipment Biosound Phase 2 VCR ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 13 REAR OF BIOSOUND PHASE 2 VIDEO PRINTER MODE 1 MODE 2 DIP SWITCHES TO VIDEO PRINTER CONNECTION PHASE 2 REAR FUSE SPECIFICATION POWER SUPPLY EMEN NEC VIDEO Figure 3 Ultrasound Assessment Equipment Biosound Phase 2 Printer ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 14 CUFF kPa MAP was OPERATION PULSE 888 To make ter frire LESES ds 20 y ct pow ALARA SWITCH Y TONE f 8 PATENT 4145054 WS PATENT a360020 PRINTER N DATA INTERFACE Parent FUNDING GEN UE IUS EEE 4 a hana a EAT QA POS II A Art e de beef 114 PAY 54 6 tres agn SOUP long Oe Mare ttg e LINE POWER PRINIFR i wr o beg IT 53 aq saw ABRA 4 pe fon 1 curr commecton di Yoma eane
98. st turned on It is essential that the Dinamap be in Manual Mode at all times The IBM XT computer is then turned on After receiving replies to prompts for date and time correction the IBM XT computer displays a C gt prompt The sonographer then types the command GETBP on the IBM XT keyboard and presses the ENTER key The computer prompts the sonographer for the participant ID number by displaying the following ENTER PARTICIPANT ID ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 37 The sonographer then enters the field center letter followed by the participant ID number and presses ENTER If a file for that participant already exists the monitor will display the message X12345 ALREADY EXISTS DO YOU WISH TO OVERWRITE The computer program is not designed to save more than one file on any participant If the response entered by the sonographer is n the program automatically ends and returns the computer to the DOS prompt If the response entered is y or any other key except n the existing file will be overwritten by the file being created during this study After the participant ID number has been accepted by both sonographer and computer the IBM XT computer monitor will display the message Ready to take blood pressure 7 3 2 486 Computer To initiate the ultrasound study flow program type aricscan at the C gt prompt and press ENTER The date appears If it is correct press the
99. stic Ultrasound Skip Section 6 3 Chapter 7 in Diagnostic Ultrasound Skip Section 7 3 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 a A 16 Pignoli P Termoli E Poli A Oreste P Paoletti R 1986 Intimal Plus Medial Thickness of the Arterial Wall A Direct Measurement with Ultrasound Imaging Circulation 74 6 1399 1406 Fact Sheet on Heart Attack Stroke and Risk Factors 1987 American Heart Association Dallas TX Pages 132 143 Coronary Artery Disease Risk Factors From Cardiac Nursing Coronary Risk Factor Statement to the American Public 1987 American Heart Association Dallas TX Grundy S M 1986 Cholesterol and coronary heart disease JAMA 256 20 2849 2858 Eron Carol 1988 Young hearts Science News 134 234 236 Stamler J Wentworth D amp Neaton J D 1986 Is the Relationship Netween Serum Cholesterol and Risk of Premature Death From Coronary Heart Disease Continuous and Graded JAMA 256 20 2823 2828 Enos W F Holmes R H amp Beyer J 1953 Coronary Heart Disease Among United States Soldiers Killed in Action in Korea A Preliminary Report JAMA 152 1090 1093 Reprinted 1986 JAMA 256 20 ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 A 17 Articles of Interest High Resolution B Mode Ultrasound Scanning Methods in the Atherosclerosis Risk in Communities Study ARIC M G Bond et al J
100. t 10 defined sites on the near and far walls within this area Following a preliminary transverse scan the sites to be examined are longitudinally visualized in the middle third of the B mode image screen with the wall boundaries oriented vertically as nearly as possible on the screen 6 1 Priority for Boundary Visualization In most instances it is not possible to simultaneously obtain high quality longitudinal images of both the near and far wall boundaries of the arterial segment being examined in the same image frame This condition results primarily from the highly specular nature of the ultrasonic reflections from the blood intima boundaries and the general deviation of the arterial geometry from a cylindrical shape Consequently priorities must be placed on which arterial wall boundaries should be visualized with the others being visualized if possible but with potentially lesser quality The two boundaries to be visualized first are the media adventitia boundary on the far wall and the adventitia media boundary on the near wall This permits the outer boundaries of the media to be identified and an estimate of the arterial diameter to be measured The third boundary the far deeper wall blood intima then is visualized while maintaining good images of the first two boundaries This permits a measurement of the far wall intimal medial thickness Fourth if possible without losing this third boundary the intima blood boundary on the nea
101. ter 30 sec T 12 33 50 BBA13053400130533093082132068 A second standing bp will taken in twenty seconds After the first standing pressure is taken and the cuff is fully deflated the IBM screen will read RES IBM Computer Monitor Received command to take first standing bp after 30 sec T 12 33 50 BBA13053400130533093082132068 A second standing bp will taken in twenty seconds deca d Ready to take blood pressure ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 53 Press Y and ENTER on the 486 computer keyboard The 486 screen will now read 486 Computer Monitor CAL 5 rar IBM Canone i Monitor E A SECOND STANDING pressure Ready to take blood pressure will be taken after 20 seconds E Received command to take first standing bp When yellow cuff light stays off after 30 Sec cc MEER press Y and ENTER on Dell CSA DAD Y TE keyboard 0 de Xr px Dp 12 33 50 BBA13053400130533093082132068 A second o bp will taken in at een S E poc EE o Ready o take blood pressure Do o B The second standing blood pressure will be taken automatically at the time interval Mc A ed by the protocol The IBM will read a Computer Monitor A IBM Computer Monitor Received command to take first standing bp after 30 sec us T 12 33 50 BBA13053400130533093082132068 B A second standing bp will taken in twenty oO us dE a pe ios SAU e ws seconds Ready to take blood p
102. the Calculate menu b Press the first menu key to display Distance menu i C Press the first menu key again for Distance plus The cursor will appear in the upper portion of the screen Place cross hair in position d Adjust video gain to usual range 30 50 and adjust TGC settings for optimal imaging TGC minimum on right top maximum on left bottom stairstep configuration 8 2 6 The sonographer verifies that the computer monitor indicates the RIGHT COMMON OPTIMAL is to be scanned 8 2 7 The ultrasound transducer is moved proximally toward origin heart to view the distal centimeter of the right common carotid artery ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 58 8 2 10 8 2 11 8 2 12 8 2 13 8 2 14 8 2 15 8 2 16 The cursor is placed in the lumen as described in Section 6 3 2 The best possible image of the right common carotid artery in the optimal angle is obtained as outlined in Section 6 1 and 6 2 3 The sonographer presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape When the sonographer is ready to image the next site he she presses the NEXT SITE footswitch or presses the NEXT SITE switch on the sonographer box to advance the program to the next site Confirm advancement of the program by verifyuing that the next site to be scanned in highlighted in yellow The transducer is moved distally t
103. the Ultrasound Reading Center Ultrasound Reading Center 4310 Enterprise Drive Suite C Winston Salem North Carolina 27106 Mailing is by services guaranteeing package arrival at the Ultrasound Reading Center no later than mid afternoon on the Wednesday following the mailing 11 5 Verification of Mailing Contents The contents are verified upon receipt of shipment at URC If there are any discrepancies the field center will be notified ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 84 12 POLICIES PROCEDURES FOR REPORTING B MODE ULTRASOUND RESULTS 12 1 Routine Reporting 12 1 1 Routine Report by Field Center to Participant A clinic visit report is issued by the field center informing the participant that an evaluation will be made of the ultrasound examination and that further notification will be made ONLY in the case of unusual findings A sample letter appears below Portions of the carotid arteries blood vessels in the neck were measured We will contact you and your physician if the opening of an artery is narrowed to 2 millimeters or less 12 1 2 Routine Report from Ultrasound Reading Center to Field Center The ultrasound report to each field center is a weekly list of participant studies read the previous week and an alert designation whenever an alert condition was detected at the Ultrasound Reading Center The list will consist of the following information a Participant Identifica
104. the sonographer includes but is not limited to site visits verbal communication over the phone or in the form of taped comments of reviewed scans written communication in the form of formal reviews of scans statistical evaluations of performance and recertification reports ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 81 10 SUMMARY OF CHIEF SONOGRAPHER DUTIES The chief sonographers duties are a vital part of maintaining the quality of the ultrasound data at the field centers The estimated time effort required exclusive of training new sonographers is 10 percent A summary of duties is listed below a Assists the Ultrasound Reading Center in training new sonographers as described in Section 9 1 3 Stage 3 b Responsible for reviewing sonographer scanning performance as described in Section 9 3 1 C Responsible for reviewing the quality assurance data prepared by the Ultrasound Reading Center for the field center and for each sonographer at that field center Current values and trends are reviewed and if problems arise the chief sonographer and the Ultrasound Reading Center will work together with the sonographer to implement solutions d Responsible for reporting ultrasound area equipment problems to the Ultrasound Reading Center e Responsible for scheduling preventive maintenance visits and other service calls as needed Before each visit or call to Biosound a list of problems are
105. tion numbers b Participant last name first and middle initial Ci Date of birth d Race and gender e Examination date fu Alert Yes or Blank 12 2 Procedures for Non routine Results 12 2 41 If lumen narrowing to 2 mm or less is detected by the sonographer The sonographer identifies a study as a possible alert and notes the reason on the log sheet The URC identifies the study for review and confirmation by the URC ultrasound clinician Such reviews take place on a regular basis prior to the routine reading by URC readers 12 2 2 If lumen narrowing to 2 mm or less is detected by the reader The study will proceed through the routine reading process The reader identifies a study as a possible alert The study is reviewed by the URC ultrasound clinician Such reviews take place on a regular basis 12 3 1 Report from Ultrasound Reading Center to Field Center A report is sent by the URC to the field center listing all studies for which possible alerts were cited by the sonographer This report will indicate which studies were and were not confirmed as alerts ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 85 12 3 2 Reporting of Confirmed Alerts by the Ultrasound Reading Center to Field Center A report is sent by the URC clinician to the field center with a brief evaluation The field center then contacts the participant and the participant s provider of medical care The URC sends a report summariz
106. to the ultrasound table to maintain this position Explain the blood pressure measurement procedure as the cuff is put into place Be sure to explain that repeated blood pressure measurements will be obtained automatically Advise the participant that the first inflation is always somewhat uncomfortable due to lack of individualized adjustment by the machine to that particular person s blood pressure Subsequent readings require a lower pressure and will cause less discomfort If an adequate systolic blood pressure measurement is not obtained at the ankle verify that the cuff has been wrapped appropriately and has not slipped If upon inflation the cuff rolls down toward the foot the cuff should be reapplied more snugly If the cuff unwraps upon inflation a larger cuff may be substituted If a cuff is rewrapped or changed an additional manually triggered BP is taken Observe the participant for a tendency to stretch the calf or wiggle the foot during the blood pressure reading If it occurs discuss the effect of this action with the participant before the ultrasound scan is started stressing the need for the leg and arm to be kept still during the blood pressure readings Discomfort during the blood pressure measurement may indicate that the ankle cuff has been applied too tight not applied smoothly or that it is too narrow Once the ankle blood pressure is completed the cuff is removed from the ankle The participant s sock and or
107. uff on the left ankle if the date is an odd number place the cuff on the right ankle Apply the ankle blood pressure cuff to the lower extremity selected Socks or stocking have been removed or moved below the ankle to keep the participant s foot and or toes warm if the room is cool Where practical use the same cuff for the ankle as for seated blood pressure This information is found in the participant s chart If the participant s ankle is very large and or strongly tapered a larger cuff may be necessary While ankle blood pressures are obtained the participant should be in a supine position without any pillows or support under the legs unless this causes discomfort In most cases the participant will be comfortable in that position for the short time needed to take the ankle blood pressure Ifa participant feels that a pillow is necessary provide one and indicate on the log sheet that a pillow was used during ankle blood pressure Proper application of the appropriate cuff above the ankle of the selected leg is shown in Figure 20 or 21 Lay the cuff flat on the table the surface marked side to the patient face up with the ankle centered on the cuff For the moment disregard the over the artery marker The lower edge of the cuff from which the tubes extend should be approximately 2 to 2 1 2 inches above the medial malleolus Following the contour of the lower leg wrap the end of the cuff with the Velcro fastener over the ankl
108. ulb Optimal Internal Ready to take blood pressure 00 Bulb Far Bulb Near Verify that 012 Start Code Calibration is highlighted in yellow To mark this and each following site choose SELECT by using the SELECT footswitch The SELECT message will appear on the flow screen for approximately 10 seconds After pressing SELECT footswitch wait for 7 seconds then press NEXT SITE footswitch to move to the next site to be scanned The yellow highlight moves to the next code and the previous code is highlighted in green Do Preliminary Scan Now Press Next Site Footswitch when finished appears on Screen of the CSA Dell ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 57 8 2 Right Carotid Scan The head and neck are positioned for the exam of the right carotid The foam rubber wedge is placed on participant s left side and the head is rotated toward the foam rubber as outlined in the introduction to this section 8 2 1 Preliminary A transverse scan of the common carotid artery is performed with the patient head position and transducer interrogation angle as shown in Figure 26 The purpose of this portion of the scan is to learn the arterial geometry and orientation of the participant Using fine transducer angulations to clearly display the blood intima boundar es within the vessel the transducer is slowly moved toward the mandible until the widening of the carotid bulb and finally the internal an
109. wo criteria First the internal normally has a significantly larger diameter than the external second the blood flow velocity pattern in the two vessels as determined with Doppler ultrasound is distinctly different Used together these two considerations permit the internal carotid artery to be identified with a high degree of confidence Although tributaries originating from the external carotid artery may occasionally be viewed with B mode ultrasound to help in this differentiation Doppler ultrasound in most cases is more efficient and specific for this separation The method and criteria for this identification are as follows A B mode image is obtained of the carotid bifurcation where the common carotid artery divides In some instances the best anatomical angle will show the flow divider as well as the proximal internal and external carotid arteries In the remaining cases the flow divider and only one vessel can be seen from a single angle In those instances the other artery can be visualized by gently rocking the ultrasound transducer back and forth in angle or position or both Doppler is used to differentiate internal and external carotid arteries in these instances To obtain a Doppler sample of each artery press the DOP CUR button on the instrument panel and using the tracking ball on the instrument panel move the Doppler cursor so that it is positioned within the lumen of the branch farthest from the skin surface The DOP button
110. yellow cuff light stays off Received command to take ankle bp dii Y and ENTER on DELL CSA keyboard A 12 33 50 BBA13053400130533093082132068 After the ankle blood pressure is taken and the cuff is fully deflated the IBM screen will read outer Monitor IBM Computer Monitor SCORTA ANKLE Received command to take ankle bp Press A on the IBM keyboard When salici cuff light stays off A 12 33 50 BBA13053400130533093082132068 ae Y and ENTER on DELL CSA keyboard se Ready to take blood pressure The cuff is removed from the ankle See Section 7 5 2 for arm cuff application ARIC PROTOCOL 6a Ultrasound Scanning Procedures Visit 3 VERSION 3 0 01 95 44 Press Y and ENTER on the 486 computer keyboard The computer monitors will then read 486 Computer Monitor ti M outer Monitor MANUAL ARM Received command to take ankle bp Press M on the IBM keyboard MM A 12 33 50 BBA13053400130533093082132068 When yellow cuff light stays off a press Y and ENTER on DELL CSA Ready to take blood pressure keyboard lai c Press M on the IBM keyboard Shortly after M is pressed on the IBM keyboard the IBM computer will append the following message on the screen 486 Computer Monitor IBM Computer Monitor MANUAL ARM Received command to take ankle bp Press M on the IBM keyboard A 12 33 50 BBA13053400130533093082132068 When opi cuff 37995 stays off Ready to take blood pressure p

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