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Atherosclerosis Risk in Communities Study Protocol Manual

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1. 2 2 e e o 11 2 Content of Mailing gt gt gt gt gt gt gt gt gt gt o 11 3 Frequency of Mailing 2 2 2 2 gt e o 11 4 Package Labeling o a s 00 0 0 o o o oo oo oo 11 5 Verification of Mailing Contents e e gt gt e e o 11 6 Weekly Ultrasound Station Backup Procedures POLICIES PROCEDURES FOR REPORTING B MODE ULTRASOUND RESULTS 12 e 1 Routine Report 6 e EJ e e e J 12 2 Procedures for Non routine Results e e eee PARTICIPANT SAFETY PRECAUTIONS 2 2 2 2 o APPENDICES Li e e e Li e Li e e e e e e APPENDIX I DOPPLER SIGNAL IDENTIFICATION OF THE INTERNAL CAROTID ARTERY 2 2 2 2 oo APPENDIX II l SOFTWARE TROUBLESHOOTING gt gt APPENDIX III TROUBLESHOOTING PHASE 2 SETUP s o APPENDIX IV BIOSOUND KEYBOARD 2 2 2 2 2 gt o APPENDIX V LOG SHEET REFERENCE e 2 2 2 o o APPENDIX VI VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM APPENDIX VII WEEKLY SHIPPING LOG e 2 2 2 gt 2 o APPENDIX VIII INFORMATION REFERENCE SHEET o APPENDIX IX READING LIST de 0 a Li 88 90 90 90 91 91 91 91 93 93 93 A 1 A 3 A 7 A 8 A 9 A 12 A 14 A
2. oom onn Sen eo ben ore vr SUPER VHS CASSETTE LABELING reo gt n sy ere e er e e m_ _ _ a ON THE CARE CASSETTE LABEL er Fae ae IN SAME DERE DIRECTION _ _ _ r r_ rr Vel a wy Uday ae re s ro lt TOP PLACE CASSETTE amp 7 PARTICIPANT LABELS HERE PANTICIPANTS 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 Visit 4 Version 4 0 08 97 A 13 ene VIS ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 A 14 APPENDIX VII WEEKLY SHIPPING LOG WEEKLY SHIPPING LOG SHIPPING LOG 1 SHIPPING NUMBER 2 NAME OF SHIPPER 3 SHIPPING TO 4 REPORTING PERIOD STARTING DATE _ __ __ mn dd yy ENDING DATE _ _ __ mm dd yy 5 NUMBER OF ITEMS TYPE OF ITEM NUMBER SENT NUMBER RECEIVED A DATA DISKETTES B 12 LEAD ECG PAPER TRACINGS CL PAPER ECG RHYTHM STRIPS D PARTICIPANT BLOOD SAMPLES E ULTRASOUND VIDEO CASSETTES F BACKUP TAPE CARTRIDGES Ge PAPER FORMS LIST TYPE ul 6 COMMENTS CONCERNING SHIPMENT CONTENTS Tia SENT DATE L L TUE S AM FM 8 INITIALS OF STAFF MEMBER PREPARING SHIPMENT RAARARARAUULAAUARAUAAARAARRUARAAARAARARRARAARAAURUARRUARAAARARARUAUAAMAUAAARAUAAARAURARARRAR 9 COMMENTS ON CONDITION OF TOTAL SHIPMENT ON ARRIVAL 10 ARRIVE DAT
3. Press E to exit the blood pressure program ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 Left Leg Center lower leg with center of cuff Fabric velcro on outside ui Entire cuff tr rotated medially th u cs tu mm t Medial malleous Figure 19 Blood Pressure Cuff Placement Left Ankle ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 65 Right Leg Center lower leg with center of cuff Fabric velcro on outside Fabric velcro Entire cuff rotated medially Velcro hooks Medial malleous Figure 20 Blood Pressure Cuff Placement Right Ankle ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 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 head 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 t
4. ARIC PROTOCOL 6A o Internal Carotid Arter External Carotid Artery Time Ultrasound Scanning Visit 4 Internal Carotid Artery External Carotid Artery Version 4 0 08 97 33 Proximal Common Carotid Arte Frequency Figure 16 Doppler tracing Combination of Internal and External Carotid Flow Patterns Figure 17 Biosound Screen Calibration Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 Common Optimal Angle Bifurcation Internal Bifurcation Far Wall Bifurcation Near Wall Right Side Figure 18 Image As Seen On Biosound Monitor ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Left Side i 5 Hf Proper Cursor Placement Version 4 0 08 97 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 examination table 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
5. Kalk iniii PTESALEA LETI w top n x Veapets ondoso am i A ni uil sell t a 001 rompi te n B N hr app e ib nl Tested lla dds IT LLLI eer tuertab vo Bei lnn S TE x rta af i E a N Eee BA gt po OE Ft JEE gt x by ee e i a LA ur 6 SEER x 7323 A adie s R f i F a Z oe E FF B Pa ig a _ Li a ese a0 f n LI i t ae n ni E n 3 DL I I poiat un et spari 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 wal interface Figure 12 Common Carotid Artery all four boundaries visualized ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 32 Right Carotid Bifurcation 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 The Bifurcation ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 Frequency Figure 14 Doppler Tracing Frequency Figure 15 Doppler Tracing
6. d When all entries have been made press the ESCAPE key twice to reach the Main Menu Press the record and pause keys on the VCR to place the VCR in pause record mode The Doppler cursor will appear on the image screen upon boot up Place it in the middle section of the screen Note The green DOP CURSOR key operates as a toggle key 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 Ce 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 dimension of the white transducer plate is parallel to the long dimension of the
7. key to mark the boundary Center the on the left side of the boundary representing the far wall Align the measurement bar in a straight line The measurement for the lateral boundaries will be displayed on the screen in cm If the geometry is correct the two measurements displayed will be within 10 of each other verify the geometry status If the geometry is correct no action is required If the geometry is out of the acceptable range re acquire the image trying to image the vessel per protocol see above If during the second attempt the vessel cannot be imaged to meet the acceptable range the sonographer should call the Biosound representative and request instructions for resetting the geometry The Biosound technician will step the sonographer through the procedure to correct the geometry Once the geometry is corrected repeat the phantom scan for the URC The sonographer moves the 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 10 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 b
8. See Section 7 5 2 for arm cuff appl After cuff light goes off press any key to continue from the ankle 08 97 Version 4 0 it 4 151 Ultrasound Scanning V ARIC PROTOCOL 6A 46 The computer monitors will then read uter Monitor 486 Com N A z O Hi N o 5 3 2 Press M on IBM keyboard to take MANUAL ARM blood pressure to calibrate Dinamap PRESS ANY KEY TO CONTINUE s pressed on the i Shortly after M te blood pressure IBM keyboard the IBM computer will append the follow screen tia inl M on IBM to Press the ing message on itor puter Mon IBM Com d command to take ankle bp ive g Bi 50 BBA13053400130533093082132068 233 A 12 Ready to take blood pressure d command to take manual bp Receive namap i ibrate the d ill cal This w After the manual blood pressure is taken the IBM screen will read itor uter Mon IBM Com Qy Q A w 3 a q E x ed 4 O 4 Y sei O 16 Oo Q gt dl 16 Ul m This will calibrate the dinamap nue press any key to cont ht goes off ig After cuff 1 08 97 Version 4 0 4 isit Ultrasound Scanning ARIC PROTOCOL 6A 47 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 Press B on the IBM keyboard to take computer ARM blood pressure PRESS ANY KEY TO CONTINUE Press B on the IBM to ini
9. 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 diameter than the external 2 the blood flow velocity pattern in the two vessels as determined with Doppler ultrasound is distinctly different See Appendix I for detailed information on use of the Doppler to distinguish between the internal and the external arteries Used together these two considerations permit the internal carotid artery to be identified with a high 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
10. are performed per the above schedule 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 positioned closest to the head of the table Figure 8 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
11. arrow keys to back up to correct any type O s The program will not allow blank fields to be skipped except the field for middle initial ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 39 Do not use numeric key pad to enter demographic information Type the Participant ID using the field center letter as the first digit followed by the six digit participant number and press the ENTER key Type the Visit Code using two digits and press the ENTER key Type the Sonographer ID using three digits and press the ENTER key Type the Cassette ID and press the ENTER key Type participant s first initial middle initial and last name gender race and date of birth pressing the ENTER key after each entry If a correction is necessary use the left arrow key to back up within the same field Use the up arrow key to toggle back to a previous field VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 DEMOGRAPHIC INFORMATION PARTICIPANT ID T123456 MACHINE ID VISIT CODE 07 SONOGRAPHER ID 098 CASSETTE ID TESTOO1 PARTICIPANT NAME GENDER RACE DATE OF BIRTH TODAY S DATE IS CORRECT Verify that all information is correct then type y and press ENTER 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 file If information needs to be corrected follow instructions above Note If n is en
12. 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 Visit 4 Version 4 0 08 97 a EQUIPMENT MAINTENANCE Detailed records of equipment maintenance are to be kept at each field center by the chief sonographer 4 1 Biosound Phase 2 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
13. 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 sonographer should consult with their immediate supervisor ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 42 2 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 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 Table 1 Determination of cuff size based on arm circumference Cuff Size Arm Circumference Small Adult lt 24 cm Adult 24 to 32 cm Large Adult 33 to 41 cm Thigh gt 41 cm The ultrasound part of the exam begins Before activating the n
14. 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 2 and 8 3 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 visualized A preliminary transverse scan as described in Section 8 2 2 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 angle 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 26 may extend into the common carotid
15. optimizes the arterial interfaces When the best possible image has been obtained based on guidelines presented in Section 6 2 he she simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape The sonographer presses the SPACEBAR TO EXIT THE LEFT SIDE The messages on the computer screen will prompt the sonographer to execute sitting and standing blood pressures as described in Section 7 5 Once the automatic blood pressure is finished the participant is thanked for their cooperation and escorted from the room The sonographer presses any key on the 486 keyboard 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 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 The 486 screen will now read ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 NND Lesion Y N Sonographer Impression E G Deviations in Protocol B Mode BP Correct LAST ADDRESS 8 3 22 When the Comments screen appears the sonographer types his her comments for the left side images and presses ENTE
16. 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 9 When the near and far wall reflections are at their brightest and the vessel is at it s most circular visualization mark this point on the tape for the Ultrasound Reading Center ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 The geometry of the Phase 2 is checked by maintaining the image from above Clear the crosshair from the screen while holding the image steady Freeze the image using the freeze key Using the x crosshair from the Distance Distance x menu center the x on the lower axial boundary and press the menu key for place to mark this boundary Then move the x to the top axial boundary and center the x on this boundary Align the measurement bar in a straight line The measurement for the axial boundaries will be displayed on the screen in cm Press escape on the keyboard to exit the distance x mode Then select the Distance Distance mode to measure the lateral boundaries Center the on the left side of the boundary representing the near wall and press the place
17. shown on Figure 17 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 28 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 18 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 imaging 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
18. so that remedial steps can be taken to improve visualization in those sites 9 2 5 Scanning Process Control 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 ha 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 review the scanning protocol with the chief sonographer 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 ef
19. states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 2 13 The program automatically advances to RIGHT BIFURCATION FAR WALL The sonographer confirms advancement of the program by verifying that Right Bifurcation Far Wall is highlighted 8 2 14 The computer monitor indicates RIGHT BIFURCATION FAR WALL 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 simultaneously states SELECT or TONE 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 Visit 4 Version 4 0 08 97 8 2 15 8 2 16 8 2 17 8 2 18 8 2 19 8 2 20 8 2 21 69 The program automatically advances to RIGHT BIFURCATION NEAR WALL The sonographer confirms advancement of the program by verifying that Right Bifurcation Near Wall is highlighted The computer
20. 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 The second phase will include several days training at the Ultrasound Reading Center consisting of lectures demonstrations and practical laboratory experience on the following topics a Overview of the Study b Role of the Ultrasound Reading Center Ce Ultrasonic Physics including basic concepts properties of ultrasonic waves reflection at boundaries and scattering from smali objects and the Doppler effect d Overview of atherosclerosis and a detailed discussion of the normal artery wall e Pathology of Atherosclerosis f Principles of Ultrasonic Instrumentation including pulse echo imaging systems pulsed Doppler systems and spectral analysis g Basic operation of the Biosound Phase 2 h instrument Performance Monitoring Ti Basic Operation of the Custom Study Equipment Jo Principles of Ultrasound Arterial Scanning The remaining training time 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 sched
21. 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 15 A Doppler signal for a combination of internal and external carotid flow patterns is illustrated in Figure 16 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 principle NO DOPPLER EFFECT WILL OCCUR ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 A 2 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 Visit 4 Version 4 0 08 97 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 gt prompt type scan 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 gt Date If the correct date appears press the ENTER key If the date dis
22. 08 97 hy 0 eri Gi O b gt u 4 ss 8 a H When the cuff light goes off press any key to continue now read The 486 monitor will 486 Computer Monitor VISIT 4 ARIC ULTRASOUND PROGRAM 2 rd 6 wate nie o C S ef yboard Press T on the IBM ke to take STANDING blood pressure TE n PRESS ANY KEY TO CONTINUE The screen on the IBM will now read 08 97 Version 4 0 Ultrasound Scanning Visit 4 ARIC PROTOCOL 6A 61 IBM Computer Monitor Received command to take sitting bp after 30 sec S 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Received command to take first standing bp after 30 sec The IBM computer will automatically wait the 30 seconds required before taking the first standing 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 IBM Computer Monitor S 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Received command to take first standing bp after 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 62 IBM Compu
23. 15 A 17 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 4 5 6 7 8 9 10 il 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Right Manual 6A Ultrasound Assessment FIGURES Ultrasound Assessment Equipment Biosound Phase 2 VCR Ultrasound Assessment Equipment Biosound Phase 2 Printer Ultrasound Assessment Equipment DINAMAP Monitor e e e e Ultrasound Assessment Equipment Computer PC 486 Ultrasound Assessment Equipment Tower PC 486 e e o Ultrasound Assessment Equipment Computer IBM XT e a e o Ultrasound Assessment Equipment Cabling Connections Reference Phantom Placement gt gt sos gt gt Cross Section or Transverse View of 6 mm Phantom Target Phantom Filament Images e e o Schematic of Carotid Artery Segments Interrogated e e o Common Carotid Artery all four boundaries visualized The Bifurcation e gt Doppler Tracing Internal Carotid Artery e e e e o Doppler Tracing External Carotid Artery eseas Doppler Tracing Combination of I
24. 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 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 In each scan a 6 mm diameter simulated vessel and one scan of a set of filaments within the phantom are visualized The following instrument performance protocol is done by a certified sonographer at each field center on the second and fourth Wednesdays after the ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 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
25. 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 cycles marking the site on video tape The program automatically advances to the next site 8 2 7 The sonographer confirms advancement of the program by verifying that the Right Bifurcation is highlighted 8 2 8 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 arterial interfaces are optimized at this site and angle 8 2 9 The computer monitor indicates RIGHT BIFURCATION OPTIMAL 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 simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 2 10 The program automatically advances to RIGHT INTERNAL OPTIMAL The sonographer confirms advancement of the program by verifying that Right Internal Optimal is highlighted 8 2 11 The transducer is moved distally to the proximal centimeter of the internal carotid artery 8 2 12 The computer monitor indicates RIGHT INTERNAL OPTIMAL 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 simultaneously
26. 8 97 A 16 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 Visit 4 Version 4 0 08 97 A 17 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 From 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 Frederick W ai Ph D Third Edition Publisher W B Saunders Company Harcourt Brace Jovano
27. A Ultrasound Scanning Visit 4 Version 4 0 08 97 11 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 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 Visit 4 Version 4 0 08 97 12 BIOSOUND PHASE 2 REAR PANEL SHOWING VCR OUTPUT TO COMPUTER CAMERA LO CONTROL VIDEO CASSETTE RECORDER UL LABEL INPUT FROM SONOBOX 3 AUDIO OUT OUTPUT OUTPUT TO TO SS TRACKER 2 TRACKER y v TRIG IN BIOSOUND PHASE 2 REAR PANEL CONNECTIONS 1 RF IN MONITOR AUDIO SHORT CORD CONNECTS TO VCR Soon GERE AUDIO VIDEO VIDEO VIDEO IN PRINTER Figure 1 Ultrasound Assessment Equipment Biosound Phase 2 VCR ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 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 NEC VIDEO Figure 2 Ultrasound Assessment Equipment Bio
28. Atherosclerosis Risk in Communities Study Protocol Manual 6A Ultrasound Assessment Scanning Procedures For Copies Please Contact ARIC Coordinating Center Department of Biostatistics CSCC 203 NationsBank Plaza University of North Carolina at Chapel Hill Chapel Hill NC 27514 Visit 04 Version 4 0 August 1997 FOREWORD This manual entitled Ultrasound Assessment 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 18 Manual 12 on Quality Assurance contains a general description of the study s approach to quality assurance as well as the details for quality assurance for the different study procedures ARIC Study Protocols and Manuals of Operation 1 General Description and Study Management 2 Cohort Component Procedures 3 Cohort and Community Surveillance 4 Pulmonary Function Assessment Retired 5 tiecirocarilograniy 6 Ultrasound As
29. E _ _ TIME _ __ AM PM ll INITIALS OP STAFF MEMBER RECEIVING SHIPMENT __ __ _ ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 A 15 APPENDIX VIII INFORMATION REFERENCE SHEET I l b e ee a ee 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 Ultrasound Coordinator 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 Blaine Freeman Dave Struewing Alan Voils Mike Meador 2 URC 910 759 2137 Fax 919 759 2139 Peripheral Equipment Ultrasound software Bilbo box footswitches and cables 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 Anne Safrit or Delilah Cook Sonographer Certification and Review 3 Dell Computers Damian Brown 800 284 1200 ext 3967 or local computer repair facility 4 Dinamap Johnson amp Johnson Critikon Pam Thornbury 800 255 2500 or 919 852 2733 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 0
30. ES 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 Ci 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 written and given to them in case special test equipment or boards are required f Responsible for communication with the Ultrasound Reading Center ge Responsible for sonographer recertification as outlined in Section 9 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 90 11 LABELING AND MAILING TO THE ULTRASOUND READING CENTER 11 1 Labeling of Video Cassettes and Di
31. IT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 Press S on the IBM keyboard to take SITTING blood pressure PRESS ANY KEY TO CONTINUE The sonographer explains to 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 59 these positions with as little movement as possible Following these guidelines the sonographer then asks the participant to sit 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 Ready to take blood pressure 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 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 will read ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0
32. ITES 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 11 Ultrasound examination is attempted at 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 w
33. ORM PRELIMINARY SCAN CALIBRATION COMMON BULB INTERNAL BIFURCATION BIFURCATION PLEASE WAIT Last site selected PRESS SPACEBAR TO EXIT RIGHT SIDE When ready to select image for site press Select footswitch Repeat this procedure for each site on the right side When finished with the right side press the spacebar to exit right side The highlight will move in a loop fashion Example when the last site 92 is selected the highlight will move back up to 012 The highlight is in a loop The current side can be exited at any time regardless of the location of the highlight by pressing the spacebar ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 53 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 PERFORM PRELIMINARY SCAN CALIBRATION COMMON BULB INTERNAL BIFURCATION BIFURCATION Stopping VCR Please Wait IN PAUSE MODE Last site selected PRESS SPACEBAR TO EXIT RIGHT SIDE Pause Option Available at any time on the right or left side Press P on the 486 keyboard This key works as a toggle switch In Pause Mode message will appear when the VCR is stopped Scanning can be resumed by pressing P again ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 54 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 CALIBRATION COMMON BULB INTERNAL BIFURCATION BIFURCATION oc BIFURCATION RIGHT Last site selected PRESS SPACEBAR TO EXIT RIGHT SIDE QC screen m
34. R to advance the program Following comments is a series of questions The sonographer uses the ARROW keys to select the appropriate answer and presses ENTER to advance to the next field Verify that all answers are correct then type y and press ENTER 8 5 Ultrasound Conclusion Upon completion of the final comment question screen the sonographer will be prompted by the following screens to copy participant files to a floppy ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 74 u _ RIGHT SIDE EXTERNAL Internal Carstid Artery External Carotte Artery gt 3 INTERNAL TRANSVERSE B MODE IMAGE ROTATE TRANSDUCER HEAD 90 Right Carotid Artery Transverse Scan Investigation Procedure Figure 21 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 e EXTERNAL INTERNAL SKIN B MODE IMAG LONGITUDINAL Figure 22 Right Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 76 RIGHT SIDE ae EXTERNAL INTERNAL SKIN B MODE IMAGE TRANSDUCER HEAD 90 LONGITUDINAL Figure 23 Right Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 INTERNAL SKIN EXTERNAL IA ROTATE TRANSDUCER HEAD 90 _ LONGITUDINAL Figure 24 Right Carotid Artery Transv
35. SX unit Interpretation of the ultrasound examination performed at the Ultrasound Reading Center URC is described in the Manual 6B Ultrasound Assessment Reading Protocol ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 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 and Visit 4 1996 1998 is the Biosound Phase 2 The Biosound 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 over the course of these six years 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 si
36. all 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 he fa and the adven ja media bounda on the nea all This permits the Sue 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 is visualized An image of the common carotid artery in which all four boundaries are visualized is shown in Figure 12 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 25 along the vessel where the internal carotid artery and external carotid artery begin A second but less clearly delineated is the location where the
37. 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 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 8 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 Ci 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
38. 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 e The URC will continue to monitor levels of visualization 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 study 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 no 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 per
39. ay come up on either side or both sides or not at all QC can be repeated by using the up or down arrow keys to position highlight on QC code After the richt side scan has been completed press the spacebar to exit the right side The computer monitors will then read 486 Computer Monitor VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 Press B on the IBM keyboard to take computer ARM blood pressure PRESS PgUp to RETURN TO RIGHT SIDE OR ANY OTHER KEY TO PROCEED TO LEFT SIDE ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 55 H 0 ort 6 gt u p A A 0 O gt gt a bi pres 11 be i After the data has been collected a copy of the data sent to the IBM w d onto the IBM monitor copie itor IBM Computer Mon 533093082132068 50 BBA13053400130 33 N ei m take blood pressure O Ready t d command to take arm bp lve Rece 50 BBA13053400130533093082132068 33 sure B 12 pres the IBM t fully deflated LS ill read After the arm blood pressure is taken and the cuff screen wi 08 97 Version 4 0 Ultrasound Scanning Visit 4 ARIC PROTOCOL 6A 56 3 IBM Computer Monitor B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Received command to take arm bp B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure Press any key on the 486 computer keyboard An example of t
40. 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 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 transdu
41. canning Visit 4 Version 4 0 08 97 94 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 12 3 2 Reporting of Confirmed Alerts by the Ultrasound Reading Center to Field Center The URC sends a report to the field center summarizing the findings of the Clinician whether an abnormality was identified and where appropriate to suggest a clinical evaluation The field center then contacts the participant and the participant s provider of medical care 12 3 3 Reporting of Confirmed Alerts by the Field Center to the Participant An example of a letter sent to the participant in whom a carotid ultrasound alert value is confirmed appears 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 evaluatio
42. cer 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 interfere with the wall interfaces being imaged but should remain in the lumen area 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 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 Visit 4 Version 4 0 08 97 39 Landmarks Internal External Segment Tip of Flow Divider Bifurcation segment Origin of Bifurcation Common Carotid Segment Figure 11 Schematic of Carotid Artery Segments Interrogated ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 Right Common Carotid Artery PAIN Frage boeretttitrmti
43. common carotid artery begins to widen into the carotid bifurcation These landmarks are illustrated in Figure 13 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 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 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 13 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
44. de 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 Identification numbers b Participant last name first and middle initial Ce Date of birth d Race and gender e Examination date f Alert Yes or Blank 12 2 Procedures for Non routine Results 12 2 1 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 ARIC PROTOCOL 6A Ultrasound S
45. depressed 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 3 To put the crosshair cursor on the tape 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 Cz 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 4 The sonographer verifies that the computer monitor indicates the RIGHT COMMON OPTIMAL is to be scanned 8 2 5 The ultrasound transducer is moved proximally toward origin heart to view the distal centimeter of the right common carotid artery 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 8 2 6 The sonographer simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac ARIC PROTOCOL
46. dures To insure data recovery in the event that the participant files are lost before the URC receives them the following steps are taken at the end of each week on both the CSA DELL and the IBM Li Insert a blank diskette floppy in the a drive 2 A file manager has been installed on each computer The file manager can be opened by entering the following command C gt co press enter 3 Using the arrow keys to highlight the participant files saved for the week and the instructions on the screen to flag the files identify files to be copied to the diskette floppy in drive A The diskette floppy is removed from drive A and clearly labeled to identify which week of participant files are stored on the diskette floppy ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 92 The diskette is stored at the Ultrasound station until receipt of verification that the participant files have successfully been logged in at the URC The files can then be deleted from the diskette floppy and from both computer s Studies directory ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 93 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 ma
47. e NEC PC VCR and Dinamap turned on last 5 2 Biosound Phase 2 setup The Phase 2 should be turned on The IBM and 486 computers are 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 Press any key message on the Phase 2 keyboard and wait of the Phase 2 at the bottom of the unit is put into a time out mode is not appropriate the unit in a continuous mode of Therefore the operator should press D displays the main menu The menu displays finish the boot up procedure appears on the screen press the letter D for Main Menu to appear on the right monitor screen If any key other than D is pressed For study purposes a time out mode This will put operation Please note that the Doppler cursor will appear on the image screen at the time of boot up To avoid overheating the unit should be turned off when not in use for an extended period of time If the sonographer should follow start up procedures Phase 2 is off for more than one hour the Thereby allowing the unit to warm up for a minimum of 30 minutes Check the VCR display screen for VCR setting setting L Check the channel display for If the L is not displayed press the up and down arrow keys on the VCR keyboard labeled Channel until it does appear The VCR settings should be as follows Panel Settings Record L
48. e initial and press enter If the participant has no middle initial simply press enter to move to the next field 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 The program will not accept anything other than For M Press the ENTER key and type in the correct entry Race Enter B W or O The program will not accept anything other than B W or O Press the ENTER key and type in the correct entry Date Of Birth Type in the participant s date of birth 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 However using the backspace key will not erase the entry Type over the entry to correct Note If you are at the end of the demographics screen and notice an incorrect entry use the up arrow key to toggle back to make the necessary corrections If tape has not been inserted in the VCR when the program attempts to move the tape to its starting position the following screen will appear INSERT TAPE IN VCR PRESS ANY KEY TO CONTINUE Insert tape in VCR and press any key If a power failure happens during a scan a Continuation option is available After star
49. e 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 The guest sonographer must submit scans for review for certification and become certified when scanning longer than a ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 85 five days or fifteen scans within a two month period At least five scans must pass review before certification can be attained 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
50. ength 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 Next the sonographer determines which artery is the internal carotid artery This is accomplished by using the Doppler cursor to sample first one branch and then the other Press the DOP CUR key to place the Doppler cursor on the image screen The Doppler key is depressed in order to view the Doppler spectra on the Biosound screen The Doppler key is depressed 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 3 4 The sonographer verifies that the computer monitor indicates the LEFT COMMON OPTIMAL is to be scanned 8 3 5 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 Sec
51. erse Scan Investigation Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 LEFT SIDE EXTERNAL SKIN B MODE IMAGE ROTATE TRANSOUCER HEAD 90 e ae LONGITUDINAL Figure 25 Left Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 LEFT SIDE N EXTERNAL INTERNAL SKIN B MODE IMAGE TRANSVERSE ROTATE TRANSOUCER HEAD 90 LONGITUDINAL Figure 26 Left Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 LEFT SIDE INTERNAL SKIN EXTERNAL B MODE IMAGE LONGITUDINAL Figure 27 Left Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 81 LEFT SIDE INTERNAL SKIN EXTERNAL B MODE IMAGE ROTATE L TRANSOUCER HEAD 90 AGE age ae 1 4 re St rd parto BEY LONGITUDINAL Figure 28 Left Carotid Artery Transverse Scan Investigation Procedure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 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 and certification steps at the field centers 9 1 1 Stage 1 During
52. ery 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 27 artery is cessation of flow before the onset of the next systole as defined in Figure 15 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 which 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 16 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 adven
53. evel 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 Edit off Line IN VIDEO S VHS ON T120 Keyboard Settings ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 22 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 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 ap
54. ext 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 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 43 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 Press M on IBM keyboard to take MANUAL ANKLE blood pressure to calibrate Dinamap PRESS ANY KEY TO CONTINUE Press M on the IBM keyboard to initiate blood pressure 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 IBM Computer Monitor Ready to take blood pressure Received command to take manual bp This will calibrate the dinamap After the cuff light goes off press any key to continue After the manual blood pressure is taken the sc
55. fect the improvement The sonographer will continue to scan The URC will continue to monitor levels of visualization ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 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 The sonographer will review the scanning protocol with the chief sonographer The sonographer will review training materials on the principles of physics and anatomy 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 chief sonographer and the sonographer The chief sonographer will observe the sonographer perform that part of the scan which was found not to conform to standards The sonographer and chief sonographer will discuss ways to improve visualization at the specific sites The sonographer will practice that part of the scan on volunteers The chief sonographer will report back to URC on steps taken to effect improvement The sonographer will continue to scan The URC will continue to monitor levels of visualization 9 2 9 Non conforming severe The sonographer chief sonographer and study coordinator will receive written notification of the s
56. 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 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 14 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 art
57. formance 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 88 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 standards 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 images and quality assurance images fr
58. gnals ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 3 ULTRASOUND AREA INSTRUMENTATION The ultrasound area instrumentation consists of a Biosound Phase 2 ultrasound imaging system a NEC PC Video Cassette Recorder a 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 the nominal 10 MHz transducer driven 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 A 1 2 sVHS video cassette recorder VCR is connected to the Biosound Phase 2 The VCR records the ultrasound video informat
59. he 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 e the gain is set at 50 the TGC is in a stair step alignment e the focus is in the mid focus setting 2cm The transducer motor is on and there should not be any gel on the transducer Verify that Calibration is highlighted Press the SELECT footswitch to calibrate The PLEASE WAIT message will appear on the flow screen for approximately 10 seconds The program will then advance to the next site BERFORM PRELIMINARY SCAN message will appear on screen 8 2 Right Carotid Scan 8 2 1 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 2 Preliminary A transverse scan of the common carotid artery is performed with the patient head position and transducer interrogation angle as shown in Figure 21 The purpose of this portion of the scan is to learn the arte
60. he left side menu screen will appears below The IBM monitor will not change until the left side scan has been completed VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 PERFORM PRELIMINARY SCAN COMMON LEFT OPTIMAL BULB LEFT OPTIMAL INTERNAL LEFT OPTIMAL BIFURCATION LEFT FAR WALL BIFURCATION LEFT NEAR WALL Last site selected PRESS SPACEBAR TO EXIT LEFT SIDE Preliminary is performed without using any footswitches ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 57 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 PERFORM PRELIMINARY SCAN LEFT OPTIMAL BULB OPTIMAL INTERNAL OPTIMAL BIFURCATION FAR WALL BIFURCATION NEAR WALL PLEASE WAIT Last site selected PRESS SPACEBAR TO EXIT LEFT SIDE When ready to select image for site press select footswitch Repeat this procedure for each site on the left side ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 58 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 BULB INTERNAL BIFURCATION BIFURCATION Stopping VCR Please Wait Last site selected PRESS SPACEBAR TO EXIT LEFT SIDE When scan for left has been completed the sonographer presses the SPACEBAR to exit the left side The Stopping VCR message will then appear on the screen The program will then prompt the sonographer for sitting and standing blood pressures The messages on the computer screens will read as follows 486 Computer Monitor VIS
61. he 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 NEC PC VCR to control the VCR operations The IBM XT controls the Dinamap blood pressure apparatus Instructions on the computer screen from the study flow program direct the sonographer as to when to initiate IBM controlled blood pressures and when to take blood pressures manually 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 interpretation 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 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 the verbal identification by the sonographer is placed on the audio channel The frame address is later placed in a file for use at t
62. he reader station The sonographer s statement 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 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 4 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
63. 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 simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 3 13 The program automatically advances to LEFT BIFURCATION FAR WALL The sonographer confirms advancement of the program by verifying that Left Bifurcation Far Wall is highlighted 8 3 14 The computer monitor indicates the LEFT BIFURCATION FAR WALL 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 simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 3 15 The program automatically advances to LEFT BIFURCATION NEAR WALL The sonographer confirms advancement of the
64. ion coming from the video channel onto the video cassette 3 2 The Video Cassette Recorder The video recorder is a NEC 4 sVHS PC VCR It was chosen to provide superior image quality cassettes The sVHS cassettes are sent to the Ultrasound Reading Center 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 sVHS video cassettes and sent to the Ultrasound Reading Center ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 4 3 4 The 486 SX Computer The 486 SX computer is used for multiple 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 Cc 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 t
65. k 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 affect Doppler sampling 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 Visit 4 Version 4 0 08 97 BIOSOUND KEYBOARD APPENDIZ IV I III ZINIO ST ae mE ul H UOTIN TE DIE dl lt Lt Fe I om i IERI af ui E uH JE IH N HH ir Ta QUIS TU LLL jb IM lt 15 fark HAHEI gt HIHI q1 gt L I gure 08 97 Version 4 0 Ultrasound Scanning Visit 4 ARIC PROTOCOL 6A APPENDIZ V A B c D E F G oH oI oJ ARIC PROTOCOL 6A 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 starting address Sonographer ID Sonographer Impression P Poor F Fair G Good E Excellent List QC
66. llows Note To exit the scan program at any screen press Ctrl X VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 INSERT TAPE INTO VCR Is this tape a new tape Follow the instructions placing a sVHS videotape cassette in the VCR and a previously formatted 3 3 diskette If new tape type y if not type n The program automatically advances to the next screen ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 INSERT TAPE INTO VCR Is this tape a new tape Are you sure this is NEW tape If sure type Y If you typed n for not a new tape this question will be stated as follows Are you sure this is NOT a new tape 7 4 Preliminary Questionnaire VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 DEMOGRAPHIC INFORMATION PARTICIPANT ID MACHINE ID VISIT CODE SONOGRAPHER ID CASSETTE ID PARTICIPANT NAME GENDER RACE DATE OF BIRTH TODAY S DATE IS CORRECT Note Neither the machine ID nor the date can be corrected while in the study flow program If machine ID does not match your machine exit the program and contact the URC for instructions on how to correct this If date is incorrect exit the program and return to the C gt To reset the date on 486 computer type date at the C gt and press lt enter gt Follow instructions on screen Complete fields on the demographic screen using ENTER to advance to the next field and
67. monitor should indicate the RIGHT BIFURCATION NEAR WALL 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 wall echoes will deteriorate When the near wall interface echoes are optimized as outlined in Section 6 2 6 2 the sonographer simultaneously states SELECT or TONE 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 SPACEBAR to exit the right side 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 program will exit the right side If a QC site scan is required the monitor displays and highlights the code for the QC site 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 simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles ma
68. n 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 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 14 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
69. n or treatment is necessary If you do not have a personal physician the ARIC field center will be happy to work with you to arrange for a referral ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 13 PARTICIPANT SAFETY PRECAUTIONS See Manual 2 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 APPENDICES APPENDIX I DOPPLER SIGNAL IDENTIFICATION OF THE INTERNAL CAROTID ARTERY It is important to carefully distinguish between the internal and external carotid arteries using two 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 ca
70. ng 7 3 Study Preliminaries 7 3 1 IBM XT Computer Turn on the IBM XT computer After receiving replies to prompts for date and time correction the IBM XT computer displays a C gt prompt The sonographer ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 37 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 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 Note The BP program can be exited at any time by pressing E 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 scan at the C gt prompt and press ENTER The computer screen will read as fo
71. nternal and External Carotid Flow Patterns 2 2 o oo Biosound Screen Calibration Procedure e gt o Image As Seen On Biosound Monitor Proper Cursor Placement Blood Pressure Cuff Placement Left Ankle o Blood Pressure Cuff Placement Right Ankle e o Right Carotid Artery Transverse Scan Investigation Procedure Right Carotid Artery Transverse Scan Investigation Procedure Carotid Artery Transverse Scan Investigation Procedure Right Carotid Artery Transverse Scan Investigation Procedure Left Carotid Artery Transverse Scan Investigation Procedure Left Carotid Artery Transverse Scan Investigation Procedure Left Carotid Artery Transverse Scan Investigation Procedure Left Carotid Artery Transverse Scan Investigation Procedure iii 12 13 14 15 16 17 18 19 20 20 30 31 32 33 33 34 34 35 64 65 74 75 76 77 78 79 80 81 1 INTRODUCTION The ultrasound examination of the ARIC cohort participants consists of the following components 1 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 1846
72. od 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 version 4 0 08 97 49 At the 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 MOVING TAPE TO STARTING POSITION PLEASE WAIT The following screen automatically appears on the 486 computer when VCR is in start position The IBM monitor will not change until the
73. ollowing 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 Blaine Freeman 800 428 7378 and 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 Freeman 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 Coordinator 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 ARIC PROTOCOL 6
74. om 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 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 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 Visit 4 Version 4 0 08 97 89 10 SUMMARY OF CHIEF SONOGRAPHER DUTI
75. onographer s scanning performance The sonographer will stop scanning cohort participants immediately The chief sonographer will check equipment performance and preventive maintenance record 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 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 chief sonographer sonographer and the study coordinator The chief sonographer will observe the sonographer as he she performs that part of the scan which was found not to conform to standards The sonographer and the chief sonographer will discuss ways to improve visualization at those specific sites The sonographer will produce a taped scan of a volunteer of cohort age The sonographer will then make practice scans on ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 87 volunteers When the chief sonographer determines that sufficient improvement has been made the sonographer will make another taped scan of the same initial volunteer Both tapes will be sent to the URC for evaluation e The chief 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
76. pears To enter participant information on the tape menu screen do the following a Press the 4th 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 participant s last name followed by first and middle initials Press the ESCAPE key or the RETURN key Ce 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 d When finished 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 4 diskette for each for each video cassette ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 23 C 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 Es 5 1 4 diskette for each video cassette to be used with IBM XT u ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 24 6 ARTERIAL S
77. played 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 Responses to Is this tape a new tape If the tape is an old tape and you answer that it is a new tape the program will write over any scans on the tape If the tape is a new tape and you answer that it is an old tape the program will hang If the message WARNING 30 TO 15 MINUTES LEFT ON TAPE appears The sonographer can then choose to continue under the conditions stated or start with a new tape 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 10 referring to Visit 04 If one digit is entered the computer waits for the second digit sonographer Three digits must be entered If two or less digits are entered you will not be able to continue Cassette Seven digits must be entered The first should be the Field Center letter Next enter the five digit tape number followed by the check digit letter ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 Initials Enter the participant s first initial press enter Enter the middl
78. program by verifying that Left Bifurcation Near Wall is highlighted 8 3 16 The computer monitor indicates the LEFT BIFURCATION NEAR WALL The transducer is slowly tilted along the arterial axis back ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 8 3 17 8 3 18 8 3 19 8 3 20 8 3 21 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 sonographer simultaneously states SELECT or TONE 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 SPACEBAR to exit the left side 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 program will advance to the blood pressure screens If a QC site scan js 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
79. puter blood pressure is taken A Ankle blood pressure is initiated and stored in the participant file B Arm blood pressure is initiated and stored in the participant file S Sitting blood pressure will be initiated after a 30 second delay and stored in the participant file ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 T Standing blood pressure will be initiated after a 30 second delay and then a second blood pressure will automatically be taken after a 20 second delay E Exit the program Pressing E at any time during the program will exit the program and save any blood pressure data previously acquired The program will not exit until the cuff has completely deflated and the blood pressure data is stored Additional help keys c Will cancel the blood pressure just requested This can be used when the cuff is unwrapping or an error is discovered in the request i e requesting an ankle when an arm blood pressure is needed and the cuff is on the arm I Will initiate a sitting blood pressure without a 30 second delay This is used when the first attempt failed and the participant has already been resting for 30 seconds U Will initiate the first standing blood pressure without the 30 second delay This is used when the first attempt for standing blood pressure fails N Will initiate the second standing blood pressure without the 20 second delay This is used when the second standing blood pre
80. rasound studies completed the previous week Ca _ Diskettes containing the blood pressure files for the ultrasound studies completed the previous week l Gi A copy of the week s log sheet See Appendix 5 e A copy of the Shipping Log sheet for the week A video cassette containing phantom scan s if appropriate g Biosound Service Report if appropriate ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 91 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 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 Ce The shipping number from the Shipping Log sheet d Address label to 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 11 6 Weekly Ultrasound Station Backup Proce
81. reens will read IBM Computer Monitor Ready to take blood pressure Received command to take manual bp This will calibrate the dinamap Ready to take blood pressure ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 44 After any key is pressed the screens will read as follows 486 Computer Monitor VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 Press A on the IBM keyboard to take computer ANKLE blood pressure PRESS ANY KEY TO CONTINUE Press A on the IBM to initiate blood pressure Received command to take manual bp This will calibrate the dinamap Ready to take blood pressure Received command to take ankle 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 45 IBM Computer Monitor Q Q ed ui ho amp cd amp 2 a p O 4 Y amp E O O o Q gt ed Vv ph This will calibrate the dinamap d command to take ankle bp ive After the ankle blood pressure is taken and the cuff is fully deflated the IBM screen will read itor uter Mon IBM Com d command to take ankle bp ive Rece 50 BBA13053400130533093082132068 33 A 12 take blood pressure 0 gt rg g O da CONTINUE is removed lon The cuff t lca
82. rial geometry and orientation of the participant Using fine transducer angulations to clearly display the blood intima ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 67 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 using the diagrams in Figures 21 24 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 The preliminary scan is performed without using any footswitches Next the sonographer determines which artery is the internal carotid artery This is accomplished by using the Doppler cursor to sample first one branch and then the other Please note the Doppler cursor appear is displayed initially at the time of Biosound boot up The Doppler key is depressed in order to view the Doppler spectra on the Biosound screen The Doppler key is
83. right side scan has been completed VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 CALIBRATION COMMON BULB INTERNAL BIFURCATION BIFURCATION PRESS SPACEBAR TO EXIT RIGHT SIDE ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 50 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 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 CALIBRATION COMMON RIGHT BULB RIGHT INTERNAL RIGHT BIFURCATION RIGHT BIFURCATION RIGHT PLEASE WAIT Last site selected Press ENTER on keyboard or press select footswitch to select code 12 A beep verifies that the select footswitch has been pressed Please Wait is displayed for 10 seconds You must wait until it goes off The program will not advance until the 10 seconds has passed The highlight automatically advances to the next site when Select footswitch is pressed ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 version 4 0 08 97 51 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 PERFORM PRELIMINARY SCAN CALIBRATION COMMON BULB INTERNAL BIFURCATION BIFURCATION Last site selected PRESS SPACEBAR TO EXIT RIGHT SIDE Preliminary is performed without using any foot switches ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 52 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 PERF
84. rking the site on video tape The sonographer presses the SPACEBAR TO EXIT THE RIGHT SIDE The gel is wiped from the participant s neck and the head and neck are repositioned for the left side scan The arm blood pressure screen will appear The sonographer should follow directions on the screen to complete blood pressure measurement Left Carotid Scan 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 70 8 3 2 PERFORM PRELIMINARY SCAN message appears on monitor The preliminary is performed without using any foot switches 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 25 28 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 using the diagrams in Figures 25 28 The entire l
85. rm 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 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 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 Li 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
86. ry Visualization 6 2 The Carotid Arteries e o 6 3 Cursor Placement by Site and Side PARTICIPANT PRELIMINARIES o gt o o 7 1 Participant Orientation to Ultrasound 7 2 Participant Apparel gt e o 7 3 Study Preliminaries gt e gt 7 4 Preliminary Questionnaire e e e 7 5 Blood Pressure gt o 7 6 Preparation for Ultrasound Examination CAROTID SCANS gt gt o 8 1 Calibration s je a 25 OS 8 2 Right Carotid Scan e e e e gt 8 3 Left Carotid Scan gt e gt 8 5 Ultrasound Conclusion gt SONOGRAPHER TRAINING CERTIFICATION AND MONI 9 1 Training e lt e e e e 9 2 Certification e amp 2 s e W ae g System antom e e stem e e e e Phantom Examination e N UU db amp WW WwW WwW ano a OV 10 11 21 21 21 22 24 24 24 27 36 36 36 36 38 40 49 66 66 66 73 82 82 83 10 11 12 13 14 9 3 Monitoring e e e e gt e hd e e o o o 9 4 The B Mode Study Scan Evaluation Form e 2 2 e 9 5 The Lead Study Sonographer e ees SUMMARY OF CHIEF SONOGRAPHER DUTIES 2 2 2 2 o LABELING AND MAILING TO THE ULTRASOUND READING CENTER 11 1 Labeling of Video Cassettes
87. s 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 Visit 4 Version 4 0 08 97 A 19 Articles of Interest High Resolution B Mode Ultrasound Scanning Methods in the Atherosclerosis Risk in Communities Study ARIC M G Bond et al Journal 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 Visit 4 Version 4 0 08 97
88. s without being able to give sufficient prior notice to allow for a reschedule of the participant s visit If no provisions 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 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 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 produced by certified sonographers They will first be reviewed by the lead study sonographer 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 b
89. sessment 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 Magnetic Resonance Imaging 14 Retinal Photography 15 Echocardiography 16 Heart Rate Variability 17 Periodontal 18 DNA Repository Manual 6A Ultrasound Assessment TABLE OF CONTENTS INTRODUCTION o SELECTION OF ULTRASOUND SYSTEM ULTRASOUND AREA INSTRUMENTATION gt Sak The Biosound Phase 2 Ultrasound Imagin 3 2 The Video Cassette Recorder 3 3 The RMI Tissue Mimicking Ultrasound Ph 3 4 The 486 SX Computer e e o 3 5 The Study Flow Program o 3 6 IBM XT Computer e e o 3 7 Dinamap Automated Blood Pressure EQUIPMENT MAINTENANCE e s e es o 4 1 Biosound Phase 2 Ultrasound Imaging Sy 4 2 Video Cassette Recorder e 4 3 RMI 414 B Tissue Mimicking Ultrasound 4 4 486 SX Computer e e e e o 4 5 IBM XT o 4 6 Dinamap Automated Blood Pressure DAILY PRELIMINARIES o 5 1 Equipment e 2 e o 5 2 Biosound Phase 2 setup o 5 3 Supplies gt 0 o ARTERIAL SITES AND ANATOMIC STRUCTURES TO BE 6 1 Priority for Bounda
90. site scanned List sites not completed 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 out of sequence The sites do not need to be repeated 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 Ultrasound Scanning Visit 4 Version 4 0 08 97 A 10 Forsyth ARIC FU4001 Jackson ARIC JU4001 Minneapolis ARIC MU4001 Hagerstown ARIC WU4001 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 Visit 4 Version 4 0 08 97 A 11 LOG SHEET Pre PAT Field Ceater Uitraecend Log Sheet ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 A 12 APPENDIX VI VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM THIS END GOES INTO CASE FINST PLACE CASSETTE AND PARTICIPANT NUMBER LABELS HERE
91. skettes 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 F20001X Jackson ARIC J30001X Minneapolis ARIC M50001X 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 13 12 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 the 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 ult
92. sound Phase 2 Printer ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 14 OPERATION DINAMAP VITAL SIGNS MONITOR Cs To Computer 2 3 4 5 a ire e e e n pi MS PATENTI 4149024 pene 11 PATENT ade nga a SVATCH TONE PATTI CENDIROG on sen poni Dur nn i n A xA Pim Re ee h t tyge Erg k 1 n F UP tea tpp tg ate 1 pt ALT Torto et Fer SEE RE eS o eee ep eee vere PRINTER EEE a DT e ED e ma ie o ty Ne ree NO He ee TO BP CUFF Figure 3 Ultrasound Assessment Equipment DINAMAP Monitor ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 15 Computer PC 486 Facing Rear Panel l i SR from ee Di Sonographer s Box Red line upward power Inputs from Phase II Red line on left a Inputs from Computer Keyboard Inputs from Dinamap wi Not Used Data Interface Figure 4 Ultrasound Assessment Equipment Computer PC 486 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 u TOWER COMPUTER PC 486 FACING REAR PANEL Le i en a D ery di i n temerity gehn DS 2 u ee AC POWER TO COMPUTER a gt MONITOR 7 oe SW Te ER FROM FROM DINAMAP 3 MOBOLUNN AED INE ON LEFI NOT URED NOT URED COMPUTER MONTIOR CALLE FROM SONOROX 2 REO LINE ON NIGH FROM ADC BOX RED UNE ON FIGHT ta EE s u t Figure 5 Ultrasound Assessment Equipment To
93. ssure fails D Distensibility blood pressure This is no longer used in ARIC But is still in the program and if accidently pressed will initiate and record a distensibility blood pressure in the file ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 Mn 7 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 wor
94. ter Monitor fu Q oO G ca I cd 4 e rs D H el 4 il eh 43 O 4 Y 5 O O Y gt er Vv Q fa after 30 sec T 12 33 50 BBA13053400130533093082132068 ond standing bp will taken in twenty seconds A sec BOC aseteta ata al The 486 screen will press any key to continue ight goes off the cuff 1 When now read itor uter Mon 486 Com 3 b e x 2 VERSION 1 A second STANDING blood pressure l be taken after 20 seconds WI PRESS ANY KEY TO CONTINUE lly at the time 2 ica The second standing blood pressure will be taken automat e gt ill read The IBM w interval dictated by the protocol 08 97 Version 4 0 it 4 1S1 Ultrasound Scanning V ARIC PROTOCOL 6A 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 Ready to take blood pressure 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 IBM Computer Monitor A second standing bp will taken in twenty 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
95. tered as a response all fields will be cleared This command should be used only when the sonographer wishes to start the demographics screen over ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 40 7 5 Blood Pressure 7 5 1 Applying the Blood Pressure Cuff to the Ankle If the date is an even number place the cuff 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 If a 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 19 or 20 Lay the cuff flat on the table the surface marked side to the pa
96. 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 to the ultrasound table to maintain this position ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 41 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 a
97. tiate blood pressure Ready to take blood pressure Received command to take manual bp This will calibrate the dinamap Ready to take blood pressure Received command to take arm bp Press any key 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 onto the IBM monitor The data displayed will look something like this ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 IBM Computer Monitor Received command to take manual bp This will calibrate the dinamap 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 86 Computer Monitor IBM Computer Monitor This will calibrate the dinamap Ready to take blood pressure TEN ae LINA AAA sita Received command to take arm bp computer ARM bloot B 12 33 50 BBA13053400130533093082132068 Ready to take blood pressure After cuff light goes off press any key to continue Once key is pressed if the demographic screen does not come up immediately the VCR communication failed Exit the scan program Turn VCR off Turn PC off Then turn both back ON and start program If it fails a second time proceed with a manual scan and call the URC ASAP The IBM blood pressure program will continue even though the scan program does not Arm blo
98. tient 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 inches above the medial malleolus Following the contour of the lower leg wrap the end of the cuff with the Velcro fastener over the ankle as shown in Figure 19 or 20 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 19 or 20 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 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 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
99. tification of Experienced Sonographers A sonographer attains certification to scan based upon her ability while following the ARIC 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 study sonographer and chief sonographer must on average meet scanning standards As long as a sonographer maintains visualization consistent with the process ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 84 average of her peers and the average of monthly review scans meet protocol standards she retains certification Sonographers who submit no scans suitable for monthly review for two consecutive months will be considered to have lapsed certification Experienced sonographers may be recertified after submitting 5 scans that pass certification review 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 her 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 participant
100. ting the program over and entering at the demographic screen the continuation screen appears as below ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 VISIT 4 ARIC ULTRASOUND PROGRAM VERSION 1 2 Study file for TXXXXXX already exists Do you wish to append Y es N o R eturn to demographic screen Y continue the scan The sonographer must advance the program to highlight the appropriate site to re start the scan N To start the scan over from the beginning This will write over the existing file R Allows the sonographer to return to the demographic screen and re enter the participant ID in the event an error was made E If the sonographer is unsure of what the correct response should be this option allows the sonographer to re group by exiting until the all of the information can be checked and a decision can be made The sonographer would then restart the scan and answer questions appropriately If two footswitches are press simultaneously the program will hang A reboot will be required The scan can then be restarted at the point the error occurred CAUTION Once the program has initiated the VCR do not under any circumstance use the VCR keypad This will terminate communication between the computer and the VCR HANG Blood jefiniti Blood Pressure program keys M Manual blood pressure this will initiate a blood pressure to calibrate the Dinamap before the com
101. tions 6 1 and 6 2 3 and shown in Pogue 18 8 3 6 The sonographer simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 3 7 The program automatically advances to LEFT BIFURCATION OPTIMAL The sonographer confirms advancement of the program by verifying that Left Bifurcation Optimal is highlighted ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 71 8 3 8 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 8 3 9 The computer monitor indicates LEFT BIFURCATION OPTIMAL 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 simultaneously states SELECT or TONE presses the SELECT footswitch and holds the image for at least five cardiac cycles marking the site on video tape 8 3 10 The program automatically advances to LEFT INTERNAL OPTIMAL The sonographer confirms advancement of the program by verifying that Left Internal Optimal is highlighted 8 3 11 The sonographer moves the transducer distally to the proximal centimeter of the internal carotid artery 8 3 12 The computer monitor indicates LEFT INTERNAL OPTIMAL The cursor is placed into the correct position to
102. titia media interface next priority and finally the near wall intima blood boundary 6 2 6 Independent Views of the Far and Near Bifurcation Walls 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 bifurcation 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 image 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
103. uled time for at least one volunteer practice scan per day The volunteers should be of approximately the same age as the study cohort participants whenever possible Volunteers scanned for practice cannot be scanned again for certification purposes 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 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 9 1 3 Stage 3 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 certification volunteers Certification volunteers must be
104. vich 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 How a B Mode Image is formed A Summary Chapter 5 in Diagnostic Ultrasound Article Artifacts in Ultrasound Imaging Kremkau amp Taylor Chapter 6 in Diagnostic Ultrasound Skip Section 6 3 Chapter 7 in Diagnostic Ultrasound Skip Section 7 3 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 A 18 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 Eno
105. volunteers the novice sonographer has never scanned before The novice sonographer must demonstrate his her skill and understanding of the protocol while scanning a volunteer without prior knowledge of the participant s anatomy Scans on certification volunteers are sent to the URC for evaluation along with the normal weekiy shipment of tapes 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 The lead study sonographer may suspend the certification review process at any point if the novice sonographer fails to demonstrate an ability to consistently implement the study protocol or if the regular submission of scans for review is interrupted for an extended period of time If the review process is suspended the lead study sonographer will promptly inform both the novice sonographer and field center chief sonographer and recommend additional practice or remedial training Any scans on certification volunteers that have been approved as conforming to study standards prior to a suspension of the review process will typically be excluded from the set of ten acceptable scans required for certification Exceptions may be made at the discretion of the URC director 9 2 Certification 9 2 1 Cer
106. wer PC 486 ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 17 Vent notysed to other computer notused power cable keyboard monitor cable Dinamap cable Figure 6 Ultrasound Assessment Equipment Computer IBM XT ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 18 CABLING REFERENCE Video IN on the VCR to the Video OUT on the Phase 2 25 pin connector on the VCR to 25 pin connector on Dell CSA Red line of ribbon cable to the left Computer keyboard to the Bilbo controller box Bilbo controller box to the keyboard port on the 486 computer Footswitches to the Bilboo controller box Line A video IN on the 19 monitor to the connector on the video printer OUT connector IBM XT pin connector to the Dinamap pin connector Figure 7 Ultrasound Assessment Equipment Cabling Connections Reference ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 Figure 8 Phantom Placement ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 19 20 Cross Section or Transverse View of 6 mm Phantom Target Figure 9 Phantom Filament Images Figure 10 08 97 Ultrasound Scanning Visit 4 Version 4 0 ARTIC PROTOCOL 6A 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 begin first followed by th
107. y the filaments superficial to them Figure 10 Those gaps are used as an aid in lining up the filaments properly When a satisfactory image is seen verbally mark this point on the tape for the URC 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 03 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 This label should be placed on the video cassette The video cassette box should also be labeled accordingly At the end of each week the cassette is ARIC PROTOCOL 6A Ultrasound Scanning Visit 4 Version 4 0 08 97 10 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 f
108. 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 neck 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 arterial 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 scanni

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