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VII. POLYSOMNOGRAPHY PROTOCOL

1. ECG 5 Respiratory Bands Oximeter Probe Position Sensor from CHIME Monitor back of diaper ALICE 3 Actimeter EEG 7 EMG 3 Kerlix Wrap 1 Cannula 2 3 EOG 2 Healthdyne Neonate Infant Nasal Oral Thermistor a ECG Ensure that the baby s skin is dry and free of powder oil or perspiration to provide for good contact between the sensors and the skin A total of five ECG electrodes will be applied two Jenson hydrogel squares to interface with the CHIME monitor and three IttyBitty Contour hydrogels for the ALICE 3 connections Be sure to snap the lead wire snaps to the electrodes BEFORE placing the electrodes on the baby Peel the electrode off the plastic strip and place as follows the sites are illustrated in Figure 1 II 14 10 02 95 ELECTRODE PLACEMENT RESPIBAND PLACEMENT CHIME Monitor B Black Snap W White Snap During the PSG the red ground electrode of the CHIME monitor is not used ALICE 3 ALICE3 2 ECG leads 1 ground Figure 1 cII 15 10 02 95 Connecting Respiband to Patient Cable Respiband placements RC and AB Fasten securely but not too tight Loose ends where connector snaps should be arranged to come out of the front of the sleeper if it snaps at the midline REMEMBER no gaps in the tails Figure 2 61 16 10 02 95 CHIME Monitor Leads RA Right Arm white snap on the right chest at the nipple level LA Left Arm black snap on the left chest at the nipp
2. Standard International 10 20 placement sites for scalp electrodes CHIME designations are shown as solid circles Due to the way AL CE3 references are hardwired the ipsilateral scheme must be overridden by manually reversing the lead pins placed into M1 and M2 That is plug the scalp M1 lead into the AL CE3 input for A2 and lead for M2 into input for 1 The EEG ground will be centered on the forehead midline approximately 20 30 up from the nasion FIGURE 3 cII 19 10 02 95 e Submental EMG 1 Preparing the skin site a Clean 3 skin sites on the chin where the electrodes will be applied See Figure 4 Tip of the chin 2 Right digastric muscle as far back on lower jaw 3 Left digastric muscle as far back on lower jaw b The priority in selecting the combination of sites to measure chin EMGs are 1 The tip of the chin and the right digastric muscle 2 The tip of the chin and the left digastric muscle 3 The left and right digastric muscle 2 Preparing the electrodes a The surface and cavity of the electrode should be clean and dry to attach the adhesive washer double sided adhesive discs and to fill the cavity with electrode gel b Remove the adhesive washer from its backing strip using the blue tab and apply the adhesive washer to center the hole over the electrode cavity Press adhesive washer down to seal the surface of electrode Squeeze Signa Gel electrode gel to just fill the cavity Check
3. M EOG EMG Resp I BM mouthing sucking 3 Q 2 A codes or 2Q 3A codes eg H R IS F 1 IS W AW Awake eyes open alert or crying Feeding Awake is scored W regardless of individual parameter codes To determine Q A or IS you determine the combination of codes for each epoch and if 4 of 5 or 5 of 5 are Q parameters then the state assigned 15 If 4 of 5 are A codes then A is assigned Any other combination is IS However if one or more variables cannot be used for state determination eg EMG and or eye movements the rules change to or 3 3 Some parameters are consistent with both A and Q It is possible to have 30 codes and codes for the same epoch Score these epochs as IS Code X for movement can be used during hand scoring it is not an option on ALICE 3 60 51 10 02 95 8 Ifthe state selected differs from that displayed on ALICE 3 use the modification mode and enter your code Remember the smoothing option in 7a applies to ALICE scoring entries 9 coding proceeds identify and score EEG arousals See Step 5 Arousal Scoring Procedures for specific directions 10 After all epochs are coded return to the main menu cII 52 10 02 95 STEP 5 TRANSIENT AROUSAL SCORING RULES AND PROCEDURE DEFINITIONS An EEG arousal is an abrupt shift in EEG frequency which may include theta alpha or other frequencies greater than 16 Hz not including spindles In infants alpha frequ
4. being transferred and a fast flashing light indicates an error condition The cable from the patient box plugs directly into the 50 pin INPUT DEVICE connector Figure 8 WARNINGS AND CAUTIONS These Warnings and Cautions apply specifically to the CALVIN amplifier unit Never pick up the unit by the cover plate Always use two hands to handle the unit by its base Always place the unit on a sturdy level surface Do not set the unit on a polygraph or on top of a computer monitor Do not expose the unit to heat or direct sunlight Do not attempt to autoclave gas or pressure sterilize the unit Do not place the unit within three feet of oxygen tanks or oxygen tents Do not drape the cable to the computer over a polygraph light fixtures or medical devices not use the cable if it appears to be damaged broken or frayed Do not attempt to service the unit if it does not appear to be working properly cII 26 10 02 95 cII 27 10 02 95 CHIME Monitor Signal Evaluation Each infant enrolled in the CHIME protocol will bring her his CHIME Monitor to the sleep laboratory If the parents do not bring their monitor use the backup monitor assigned to the Sleep Lab Plug in the monitor The cartridge from the CHIME Monitor should be replaced with a newly initialized cartridge for use during the overnight polysomnogram Consult PSG cartridge parameters in Appendix B When the baby is quiet the CHIME m
5. indicator on the panel should read 20 0 Due to the least significant figure error of this type of instrument the panel may indicate 20 1 or 19 9 but this will be within the accuracy of the instrument If a number that is not close to 20 appears the instrument is not working correctly and you should contact the CHIME engineer on call Now move the selector switch to the position labeled 30 The panel meter should ideally give the reading of 30 0 but 29 9 and 30 1 are equally acceptable Now move the selector switch to the number 40 and the panel display should indicate 39 9 40 0 or 40 1 This completes the calibration check and the selector switch should be returned to the position labeled OP The instrument is now ready for operation The switch to the immediate right of the skin thermistor connector determines whether the instrument is measuring the air temperature and the skin temperature the A S position of the switch or just measuring the air temperature the A Position Choose the position that you will use for the PSG study It is recommended that the A S position be used The digital display on the front panel will now show the temperature of either the air probe or the skin probe Each is displayed for 20 seconds When the instrument is set up for both air and skin temperature the first 20 second segment after it is turned on gives the air temperature followed by 20 seconds ofthe skin temperature and repeating Although it is
6. whether respirations are regular or irregular Respiratory pauses gt 3 seconds are ignored considered an apnea for determination of I and R MOVEMENTS Note presence and type of movement and enter movement code Refer to night log for clarification as needed Phasic activity such as twitching is a body movement Arousal or questionable movement can be accepted as a movement if a time locked artifact flat or irregular erratic waveforms is seen in SaO pulse wave form channel See Alternate Montage 2 Quiet sleep allow for mouthing startles and sucking that is they are coded as in quiet sleep See Table 6 There may be a random artifactual signal on EOG perhaps a bleed in from the EEG When this occurs extra care is necessary to be certain eye movements are present If unsure do not use this channel in scoring and apply the or rule See Table 6 Refer to Appendix B for summary of coding parameters and examples Regularity or irregularity or respiration is the characteristic most useful for sleep stage scoring The EEG signal is also fairly robust A patient who is not moving with regular respirations and an EEG pattern showing high voltage slow waves or trace alterant is likely to be in quiet sleep and the scorer should be absolutely certain ofthe quality ofthe EMG and eye movement signals before assigning such a patient to indeterminate sleep Similarly a patient with low voltage irregular or mixed EEG irregular res
7. 10K ohms If impedances on EEG and EMG are less than 10K ohms the head can be wrapped with Kerlix to secure chin and head electrodes See Figure 5 for head wrap pictures Filter settings must be adjusted at the time you check impedances The following settings must be adopted by each site EEG 40 Hz 1 0 Hz EMG 45 Hz default 5 0 Hz Notch Filter ON Filter settings are toggles and directions appear on the bottom of the ALICE 3 monitor A checklist of tasks that need to be carefully performed is provided in The CHIME POLYSOMNOGRAPHY CHECKLIST Form F1 Appendix B gII 21 10 02 95 AND EMG ELECTRODE PLACEMENT FIGURE 4 61 22 10 02 95 iy FIGURE 5 cI 23 10 02 95 Pulse Oximeter SaQz Place the probe light source on the top of the baby s left foot Wrap the stretch tape around the foot so that the detector is on bottom of the foot opposite the light source Figure 6 Direct the lead wire up the body or out the bottom of the sleeper A Posey may be used to further secure the probe on the foot Position Sensor Tape to the back of the baby s diaper with the blue DOT away from the body PerCoz A nasal cannula to sample air for continuous PCO2 determination is secured front of the nares Refer to capnograph directions at each site Thermistor Prior to placement on infant check operation by blowing on sensors and observing waveforms on ALICE3 If no waveforms replace Clean se
8. 29 26 28 24 23 31 33 32 30 10 02 95 Tn order to reduce the number of sample waveforms some may contain examples of several things such as overall state an apneic event and eye movement as defined by the eye movement sensor Each waveform is numbered to help you move through the cross referencing numbers Contents are arranged by waveform type by waveform number As new examples are added new numbers will be added 61 75 10 02 95 CHIME MONITOR PSG CARTRIDGE PARAMETERS For sites where PSG staff initializes cartridge At other sites CHIME staff will provide prepared PSG and new home cartridge for each PSG cII 76 Initialize the CHIME cartridge for PSG Use Enter Infant s Information For Name enter infant s Event Record Label ERL i e tokj 12003121893 Enter infant s Date of Birth mm dd yy Enter infant s ID 5 digit Study ID Enter infant s Sex M F Address information may be left blank Enter in Comments CHIME monitor S N and Cartridge S N used during the PSG et ET Enter Monitor ALARM amp RECORD Settings 1 For APNEA set Alarm to 90 seconds and Record to 16 seconds 2 For BRADYCARDIA set Alarm to 240 Enter a negative value to disable the alarm Set Record to 80 lt 44 wks PCA or 60 gt 44 wks PCA 3 For Hypopnea Labored Breath Rapid Breath Tachycardia Sat Enter negative values to disable the alarms 4 Event Waveform Buffers values remain t
9. C3 C4 O1 O2 M1 M2 Ground will be placed on the scalp Figure 3 and held in place with electrode cream such as Elefix or Ten 20 covered with gauze squares or cotton balls Using the International 10 20 system measure the head to locate the site and mark each site with a water soluble non toxic soft marker Directions for measuring the head are outlined below 1 Refer to Figure 3 for the location of the sites Even numbers refer to the right side of the head odd numbers to the left and Z to midline 2 Use a flexible disposable washable centimeter tape and Place the 0 cm end of the tape on the nasion depression between the nose and forehead and direct the tape to the back of the head Read off the cm at the inion the protuberance at the back of the head 4 With the tape still held in place locate the halfway point of your nasion inion distance For example if the nasion inion distance is 25cm 12 5 is the midpoint Mark this point CZ 5 Leaving the tape in place measure up 10 from the nasion 2 5 in our example This is the FPZ site on the forehead Locate the ground electrode about 30 of the distance from the nasion to the hair line 61 17 10 02 95 12 Repeat this process from the inion 10 up on the midline is OZ Remove the tape and place one end on the preauricular point the depression in front of the ear and direct the tape across the head through the CZ mark to the other preauricular poin
10. Cry if needed and recheck impedances first After ALICE 3 is stopped the file will automatically transfer the data to the optical disk Note end temperature and humidity and any observation of infant condition on Form 1 Turn CHIME Monitor power off and remove PSG cartridge Put new home cartridge in monitor Remove electrodes replacing CHIME Monitor sensors if necessary Prepare baby for return to nursery or home Chart or log baby out of Sleep lab Put together all forms and cartridges needed for CHIME analysis Clean all sensors equipment as needed Back up optical file as soon as possible complete back up optical log and Form 1 cII 10 10 02 95 information 1 Verify that the RJ45 cable is connected between the PC and the Calvin amplifier box The Calvin box should be plugged into the socket marked PHONE on the computer NEVER PLUG IN PHONE JACK OR UNPLUG IT IF ALICE 3 POWER IS ON 2 Make sure your computer power is on and the ALICE 3 System Main Menu is displayed 3 Select the first option on the Main Menu Acquisition and Analysis by pressing the letter A or by clicking on the option with the left mouse button A list of montages will be displayed 4 Select the CHIME montage that you will be using for the CHIME study The screen will display the message Please wait for CALVIN self check The Patient information Screen will be displayed after the self check process is complete 5 Enter the patient s Eve
11. be simulated on the oximeter pulse channel then the cry analysis protocol must be performed See Step 23 Cry Recording followed by the identical calibration sequence as at the onset of recording cII 39 10 02 95 21 To stop data acquisition follow these steps How to exit the system From Healthdyne ALICE 3 User Manual 1994 In a normal acquisition the recording of information will stop at the time you selected on the Patient Information screen However if you want to stop the study before this time you have two options Press lt ALT gt S to stop the study and abort the program immediately Press lt CTRL gt lt END gt to discontinue the study within a three minute window When you initiate this command the system will continue to record from 0 3 minutes until it reaches the end of the current three minute time frame You will receive the message Scanning please wait At this time the software will close all of the collected files the recording will then stop and you will be returned to the Main Menu All information recorded up to this point will be saved as if the system recorded until the original study end time After completion of this sequence ALICE 3 can be turned off and the infant room can be entered Prior to removal of any electrodes check and note the end impedances of the EEG and EMG electrodes Upon removal of electrodes check their condition carefully Remove the paste remnants with s
12. difficult to know which is which by looking at the digital display it will be quite clear on the ALICE 3 screen since the skin temperature will be at a higher level than the air temperature 71 10 02 95 Replacement of Batteries The CHIME PSG thermometer is operated on battery power Periodically these batteries will need to be replaced It is time to replace the batteries when upon turning on the instrument the red PWR light fails to illuminate even though the numbers on the digital read out are functioning Ifthe batteries need to be replaced the following steps should be taken 1 Batteries are located in a compartment on the bottom of the CHIME PSG thermometer The compartment cover can be identified by the word OPEN To open this cover press down over the OPEN label and slide the cover toward the rear of the instrument 2 Four AA size alkaline batteries are housed in the battery compartment four should be changed It is sometimes difficult to remove the first battery but this can be done by sliding a small screwdriver between the first battery and the back of the case and gently prying the battery up from its holder It is relatively easy to remove the remaining batteries without the screwdriver 3 Replace the batteries making sure that the positive end marked corresponds with the sign written on the bottom of the battery compartment at each battery position Note that each battery is in the opposite position
13. from the one to which it is adjacent Make sure that batteries are firmly seated in the battery compartment and replace the compartment cover by sliding it in from the back of the case until it snaps in place 601 72 10 02 95 Appendix B Table of Contents CHIME MONITOR PSG CARTRIDGE PARAMETERS QUALITY OF INDIVIDUAL PSG CHANNELS PSG SIGNAL QUALITY FORM FORM F1 CHIME Polysomnography Checklist EXAMPLE OF INSTRUCTIONS TO PARENTS STATE CODING PARAMETER SUMMARY 5 1 95 VERSION WAVEFORM EXAMPLES Sleep State Q Quiet Asleep Preterm 34 37 wks PCA 1 2 Preterm Term 38 50 wks PCA Infants gt 50 wks PCA A Active Sleep Preterm 34 37 wks PCA 10 Preterm Term 38 50 wks PCA Infants gt 50 wks PCA I indeterminate Sleep Preterm 34 37 wks PCA 16 Infants gt 50 wks PCA W Awake All age groups Sleep State Parameters EM LEOG REOG LEOG REOG slow eye movements EEG mies EMG Resp gII 73 Waveforms by number 3 4 5 618 8 9 11 12 13 14 15 7 19 20 21 22 5 7 8 10 14 16 1 4 4 6 9 18 19 10 13 7 9 1 2 3 4 6 8 9 14 16 18 3 5 12 1 2 4 6 7 11 13 19 10 02 95 BM EVENTS Apnea Central Apnea Obstructive Apnea Mixed Apnea Hypopnea Associated Desaturation of 4 Associated Arousal Periodic Breathing Arousal SA AA CO2 Purge Artifact Movement Artifact SaO2 Removal clI 74 2 6 8 9 16 18 7 10 15 19 10 12 14 15 1 9 13 16 19 Waveforms By Number 25 26
14. has its own directives for this category 2 Principal Investigator or designated individual scans the ALICE tracings and comments in order to provide feedback to PSG personnel and CHIME Fill out the Feedback to PSG Personnel on Page 5 of Form F1 and post a copy in the laboratory if you wish 3 Consult CHIME PSG Form F1 and mail to DCAC in the weekly Transmittal Log 4 Consult CHIME Communication Log for inquiries from PSG personnel Material to be sent to DCAC l DCAC Transmittal and Disk Log sheet Optical disk with ALICE 3 patient data disk will be returned promptly De Patient identification sheet 57 CHIME PSG Checklist Form F1 pages 1 5 cII 45 10 02 95 cII 46 10 02 95 STEP 3 INITIAL ALICE REPORT Obtain a printout of ALICE 3 automatic output and file away for future reference From Healthdyne ALICE 3 User Manual 1994 Chapter VI Reports NOTE The Print Analysis Report allows you to generate reports summarizing the acquisition After selecting this option a list of all saved acquisitions will be shown Studies highlighted in green have not been saved to the optical drive and are still in the work directory The study number acquisition date patient s name and montage name is shown for each study After selecting a study the reports selected under the Printer settings option on the Configuration Modification menu will be printed Although you may not choose to print them all there are 11 available repo
15. of Spurious End tidal CO Data When the end tidal PCO gt signal becomes artifactual it should be removed from calculations for the overnight study The signal is subject to artifact usually due to displacement or plugging of the nasal catheter leading to falsely low values Accurate signals are characterized by a smooth end expiratory plateau with small variations in amplitude from breath to breath With rapid respiratory rates a smooth peak is sometimes observed rather than a plateau readings should be considered artifactual under the following circumstances a Ifthe oral nasal thermistor signal shows stable baseline flow but the PerCO2 amplitude is reduced from baseline by one third or more then that portion of the should be considered artifact and the data should not be included in summary calculations b Ifthe technician notes that the catheter has been displaced or plugged and replaces the catheter the affected data preceding the catheter replacement should be discarded c Ifthe signal is disrupted from movement secondary to catheter displacement and the signal spontaneously returns to the previous baseline the affected data should be removed Obstructive sleep apnea can occur in association with movement so this data should be evaluated carefully before it is removed from the calculations Cardiac Signals Observe the cardiac rate on ALICE 3 raw data If the ra
16. problems encountered during the night when they are not typically available Several hours prior to the next monitoring session the laboratory should again be checked preferably by technical personnel and all equipment prepared tested and settings verified For sites where PSG staff initializes CHIME Monitor cartridges see CHIME Monitor PSG cartridge parameters in Appendix B At other sites CHIME staff will provide prepared PSG and new home cartridges for each PSG Duration of Monitoring Physiological monitoring should begin prior to 9pm when all infant preparation and calibrations have been completed One and a half hours for these preparatory tasks is realistic Recordings should be terminated after no less than 8 hours of recording followed by calibration and preparation of infants for departure Staffing Infants should be under continuous observation of trained personnel in sufficient numbers to observe the baby and properly annotate the study When considering staff requirements one should take into account the need to continue annotation while the infant is awake and cared for as well as staff fatigue Funds for two staff were budgeted 1 7 10 02 95 Procedures Prior to Polysomnography It is important that arrival time in the hospital is selected so that parents caregivers are in a position to bring the infant e g after working hours and that the trip is safe in some settings parking and hospital ground escorts may have t
17. referred to as the Data Analysis System DAS will be interfaced with ALICE 3 The DAS will use 12 bit storage rather than the 8 bits used by ALICE 3 See Appendix A Recording Methods The montage to be used for the CHIME study is listed in Table 1 Since this is a research protocol and the data are to be analyzed by computer the montage as specified must be used under all circumstances Changes should only be made under exceptional circumstances and should be noted on the chart log and in the AL CE 3 initial screen or subsequent comment section To complete the monitoring montage the AL CE 3 system will be interfaced with the CHIME Monitor and a monitor that produces an end tidal gt output Audio video monitoring equipment also must be used during the sleep study Environment The laboratory should consist of two adjacent rooms one for the sleeping infant and one for the equipment The parent or caregiver will be instructed not to interfere with the infant during the study but may sleep in a nearby bed During sleep a 40W light should be on in the infant sleeping room to permit continuous surveillance through a TV monitor VCR system Sophisticated split screen monitors are optimal but not required See item list in Table 2 Access from the equipment room to the infant sleeping room should be easy in case of emergency The infant sleeping room should have resuscitation equipment and tray in case this is needed as well as a system for
18. table NOTE It is possible that movements prevent accurate identification of central and especially obstructive hypopnea Check sleep states to see whether the infant was awake If so delete the hypopnea Ifthe infant was asleep mark the hypopnea as uninterpretable on the event table This needs to be done by hand After the ALICE 3 identified hypopneic events have been verified the recording has to be scanned for possible omissions Steps a through c have to be followed and additional events must be added to the event table Enter hypopnea results as necessary cII 63 10 02 95 From Healthdyne ALICE 3 User Manual 1994 Saving Your Modifications When you have finished Scoring the entire study and the events have been validated you should save your modifications Il Press lt ESC gt from within the viewing program to access the menu 2 From the menu select to Exit to main menu S From the Main Menu select the Backup current patient option The back up process will occur automatically When the process has been completed you may proceed to display or print your results STEP 8 REMOVE ARTIFACT IN SPECIFIC CHANNELS IN ORDER TO ALLOW FOR AUTOMATED ANALYSIS AND COMPILATION OF SUMMARY VARIABLES Elimination of Spurious Oximetry Data The pulse waveform indicates the quality of the oximeter data A rounded upgoing signal should be present for each QRS complex on the ECG although the pulse waveform will be sl
19. 2 Anders T Emde R Parmelee A Eds A Manual of Standardized Terminology Techniques and Criteria for Scoring of States of Sleep and Wakefulness in Newborn Infants UCLA Brain Information Service BRI Publications Office 1971 Hoppenbrouwers T 1992 Polysomnography in newborns and young infants Sleep architecture Journal of Clinical Neurophysiology 9 32 47 Rechtschaffen A Kales A eds A manual of standardized Terminology Techniques and Scoring System for Sleep Stages of Human Subjects National Institutes of Health Publication No 204 U S Government Printing Office Washington D C 1968 Stockard Pope J E Werner S S Bickford R G Atlas of Neonatal Electroencephalography 2nd ed New York Raven Press 1992 ASDA Task Force EEG arousals Scoring rules and examples A preliminary Report from the Sleep Disorders Atlas Task Force of the American Sleep Disorders Association Sleep 1992 15 pp 174 184 cII 118 10 02 95 Appendix D Approved Supply List EEG Gold cup electrodes 48 Grass ESGH leadwire w hole 10 box specify male pins not female safety Nihon Kohden D O Weaver jacks or Contour IB Elefix Cream or Ten 20 Gold cup same as EEG with Grass paste or Contour IB Elefix Cream or Ten 20 Nihon Kohden D O Weaver Submental EMG Miniature biopotential electrodes Gereonics AgAgCl 450318 Kit includes 5 electrodes with 60 leads 2 60mg tubes of DM Davis also supplies adhesi
20. Application of Electrodes The metal side of the thermistor should be in contact with the skin The thermistor should be held in place using non allergenic tape A second piece of tape should secure the lead wire to the infant so that there is no tension on the thermistor itself Such tension could cause the thermistor to loosen from the skin and give an erroneous temperature cII 70 10 02 95 Place the air temperature thermistor over the infant s head 30 to 70 cm above the face The method of securing this thermistor will be dependent upon the arrangements used at the particular center where the study is being carried out but it is important that the thermistor be in a position where it will not be bumped by care givers during the study The instrument can then be switched on using the power switch located under the selector knob on the front panel The switch is in the on position when the toggle is pointing upward and the power light PWR is lit This is not a bright light so it may be difficult to see in a bright room If this light is not lit itis necessary to change batteries before proceeding any further Instructions for this are given in the next section The selector knob is used to check the calibration of the instrument After the instrument is switched on the selector should be set to 20 This is done by pushing in on the knob and turning until the white pointer points to the number 20 on the panel After a few seconds the digital
21. THE PSG CHECKLIST F1 FORM TECHNICAL DATA Enter BEGIN when the caregiving starts describe the caregiving then enter END when it is completed Caregiving procedures are those that generally involve the infant being in an awake state Examples include e EEG and EMG impedances values e Changes in gain to any of the channels e Any problems associated with the operation of ALICE Caregiving Enter BEGIN when the caregiving starts describe the caregiving then enter END when it is completed Caregiving procedures are those that generally involve the infant being in an awake state Examples include e Infant feedings what how long amount burping periods etc e Diaper changes e Comforting patting rocking INTERVENTIONS Enter IN when the person enters the infant s room describe the caregiving then enter OUT These are interventions that do not necessarily awaken the infant Examples include Nurse Parent Technician entering the infant s room Nurse Parent Technician touching the infant Removal or addition of blankets Re application of sensors i e EtCO2 ECG SaO2 Responses to alarms Emergency procedures ENVIRONMENTAL CONDITIONS Enter this information directly into ALICE at the time it is obtained These are changes in the environment that could affect the infant s sleeping Examples include Bi hourly temperature and humidity Sirens or exceptional noises Lights out and lights on period dimlight shoul
22. Vil POLYSOMNOGRAPHY PROTOCOL A Environment and Equipment Requirements 1 2 3 Equipment Recording Methods Environment VII 4 B Parental Education C Scheduling Q N Healthy Term Infants Apnea of Infancy Infants Premature Infants Sibling of SIDS D General PSG Procedures Q N O Preparation of Laboratory Duration of Monitoring etaffing Procedures Prior to PSG a CHIME PSG Thermometer Preparation ALICE 3 Procedure For Data Collection Polygraphic Recording Preparation 7T Application of Electrodes ECG Respiration Effort Temperature EEG Submental EMG Pulse Oximeter SaO Position Sensor P rCO Thermistor Actimeter k LEOG REOG e e oo o CHIME Monitor Signal Evaluation Connecting the Infant to Calvin Positioning Infant Environmental Conditions Assessing Signal Quality Test Signal Transfer to DAS Synchronization of Time Clocks Calibration Chart Annotation 1 11 4 11 4 VII 5 VII 7 VII 7 VII 7 VII 7 VII 7 VII 7 VII 7 VII 7 VII 8 VII 8 VII 11 VII 12 11 13 13 VII 16 VII 16 VII 16 VII 19 VII 23 11 23 VII 23 VII 23 VII 23 VII 23 VII 27 VII 28 VII 30 VII 30 VII 30 VII 31 VII 32 VII 33 VII 33 10 02 95 17 Guidelines for Re Application of Electrodes 18 Nurse Technician Caretaker Interventions 19 Adjustments of Waveforms During PSG Recordings 20 Ter
23. al supply departments 10 02 95 City Computer and Supplies 271 Schropp Ave Akron OH 44312 1 800 759 6868 DM Davis Inc 215 West 90th St NY NY 10024 PH 212 787 8519 Astro Med Grass Instrument Co 101 Old Colony Ave P O Box 516 Quincy MA 02269 0516 PH 617 775 0002 Fax 617 773 0415 The Medi Kid Co P O Box 716 Nueva CA 92567 PH 909 928 9528 FAX 909 928 1223 Nihon Kohden America 1 800 325 0283 Salter Labs 100 W Sycamore Rd Arvin CA 93203 Vendors Contour Medical Technology Inc 144 Southway Blvd La Veryne TN 37086 1 800 851 8184 Fax 615 793 6998 Gereonics Inc 4650 143 Dulin Rd Fallbrook Calif 92028 Call toll free 1 800 654 6266 8 3pm PST PH 619 731 9003 FAX 619 728 4640 Jenson Medical International P O Box 8114 The Woodlands Texas 77387 1 800 992 5487 PH 409 539 5544 FAX 409 539 5533 Neuro Supplies Inc 86 Boston Rd Waterford CN 06385 1 800 638 7693 NIMS 1840 West Avenue Miami Beach Florida 33139 1 800 654 6467 D O Weaver amp Co 565 C Nucla Way Aurora Co 80011 gII 127 10 02 95
24. alerting support personnel A sink a scale and other routinely used equipment should be handy Carpeting is desirable so that arousals are minimized but anti static treatment should be considered Overhead fluorescent lights may introduce artifacts and should not be used during monitoring Room temperature control is desirable but not always available The sleeping room is used for infant preparation Infants must sleep in a crib with sides that can be lowered easily cII 4 10 02 95 TABLE 1 PSG MONTAGE Rib Cage Abdomen Su If not used blank out the channel by inserting jumper cables in the appropriate inputs of the ALICE 3 input device DO NOT change rearrange the number order position of the channels B Parental Education As part of the PSG consent process study personnel will visit with the parent s caregiver s of the study infant to discuss the purpose of the PSG and what can be expected in the laboratory A photograph album is typically used to illustrate procedures questions are encouraged Easy to read handouts in the appropriate language should be made available for parents and caregivers These handouts should contain information about where the PSG is to be conducted what the parents need to bring and when they need to bring the baby See Appendix B for an instruction sheet example 601 5 10 02 95 TABLE 2 INFANT SLEEP LAB LIGHTING 1 Preparation Stage Standard Overhead Lighting 2 Monitoring S
25. at the beginning and at the end of the study to visually check that the amplifiers have worked correctly during the study If after looking at the Calibration Signals screen the EEG signals look differently or are not responding correctly contact Healthdyne The official start time when the rules of intervention become active is after the calibration period Some laboratories call this lights out although the lights may have been out for a long time already For this protocol designate this as begin study Chart Annotation During the PSG recording complete annotation is important for interpretation of physiological data identification of artifact and sleep state coding The behaviors and activities to be charted are outlined in Table 5A ITEMS TO BE ENTERED INTO ALICE 3 AND ON THE PSG CHECKLIST F1 FORM The CHIME STUDY PSG ANNOTATION CODING SHEET Table 5B minimizes the number of codes that are used during annotation of the PSG This CODING SHEET should be posted next to ALICE so that it can be used during the PSG a Technicians should code all infant movements and behaviors using the codes defined on the CHIME STUDY PSG ANNOTATION CODING SHEET 1 Caregiving Feedings diaper changes comforting of the infant are examples of caregiving These periods will be designated as Awake Annotate the beginning of caregiving period by typing BEGIN Use TABLE 5A ITEMS TO BE ENTERED ON ALICE to assist with the type of information that shoul
26. d be recorded during caregiving periods Annotate the end of the caregiving by typing END 2 Interventions Technical adjustments to sensors or interventions other than for caregiving These periods may still be designated to an infant sleep state It is essential that these periods be clearly and accurately described Annotate the beginning of the intervention by typing IN Describe the intervention Use TABLE 5A ITEMS TO BE ENTERED ON ALICE to assist with the type of information that should be recorded 61 34 10 02 95 17 during an intervention Annotate the end of the intervention by typing OUT b Especially note that when feeding the baby may drop off to sleep The person with the baby must notify the annotator If the mother is present she needs to be instructed not to intervene unless e g for feeding Note a pacifier is allowed during monitoring but the room should not be constantly entered to insert a pacifier which has fallen out 1 Technicians must clearly annotate Awake and Asleep periods Use the EC and EO comments to denote these periods 2 If during quiet sleep no special events happen make a notation anyway every 5 minutes Consider putting the annotation chart in plastic and keep it handy It is very important to comment EC or EO c Infant movements or behaviors that cannot be placed in one of the listed categories on the CODING SHEET should be annotated by typing in a description of the movement or behavio
27. d remain on Conditions such as lightning and searchlights that affect sleep cII 36 10 02 95 TABLE 5B CHIME STUDY PSG ANNOTATION CODING SHEET BEHAVIOR CODING PLEASE USE THE CODES LISTED BELOW AND ENTER THE CODES AS SOON AS POSSIBLE AFTER THE BEHAVIORS ARE OBSERVED Codes Definition and Description of Coding Item AWAKE vs ASLEEP Periods EO Eyes Open Indicates that the infant is awake EC Eyes Closed Indicate that the infant is asleep f infant is asleep and no behaviors are noted for 5 minutes enter EC INTERVENTIONS Enter IN then describe the intervention then enter OUT IN Person IN infant s room OUT Person OUT of infant s room Caregiving Enter BEGIN describe the caregiving then enter END BEGIN Beginning of caregiving period END End of caregiving period BM Body Movements Use BM to describe any of the body movements listed below Stretching Slow extending movement of trunk or hand or extremities Rolling over Change in position between lateral supine or prone Jerky movement Accelerated quick movement involving one or more extremities Twitching repetitive sudden quick jerky motion Writhing Twisting or turning movements squirming contorting Limb movements Movement of one or more extremities STR Startle Sudden unexpected movement usually involving all extremities FM Facial Movements Use FM to describe movements involving the face and mouth Smiling Joyful facial expression Grimacing Discon
28. during PSG and CHIME POLYSOMNOGRAPHY CHECKLIST Form 19 Adjustment of Waveforms During PSG Recordings During the PSG recordings waveforms should be continuously scanned to see whether adjustments are necessary All channels except the following may be changed during the overnight recordings EEG 1 4 position 7 temp 8 cardiotachometer 10 and endtidal 15 Expect seconds delay before ALICE implements the direction to change sensitivity Adjusting the Gain From Healthdyne ALICE 3 User Manual 1994 NOTE Only the channels with numbers displayed below the channel label abbreviation on the screen can be adjusted namely ECG chin EMG respiratory effort and airflow 1 make adjustments to a channel press lt ESC gt The channel label that you can change will be highlighted in red 2 move to another channel press the TAB key 3 When you have highlighted the channel you want to adjust press the and keys to adjust the gain up or down The signals and activity shown on the screen must be checked on a regular basis to determine if gain adjustments are necessary It is recommended that you wait for more than a minute to check the change on the screen after you have made any type adjustment 20 Termination of Monitoring Monitoring should be terminated after no less than 8 hours of recording that is 8 hours between calibrations After the end calibration the synchronization signal should
29. e PSG to insure that they reflect the TRUE time of day For technical reasons no attempt will be made to synchronize the two computer system clocks Instead a calibration signal common to both systems will be simulated at the beginning of the PSG and at the conclusion of the PSG This simulated signal will then be used to calculate the offset in time between the two systems so that events can be compared The simulated calibration signal will be created on the ALICE 3 Oximeter PULSE channel by disconnecting the Oximeter Cable from the CHIME monitor in the following manner Note the oximeter sensor should already be attached to the infant s foot Just prior to the one minute of calibration markers with CHIME monitor on for at least 5 minutes 1 Disconnect the Oximeter cable from the CHIME monitor by depressing the spring lock on the connector and removing the cable from the monitor Count to 10 one one thousand two one thousand etc Reconnect to Oximeter cable to the CHIME monitor Count to 10 one one thousand two one thousand etc Disconnect to Oximeter cable from the CHIME monitor Count to 10 one one thousand two one thousand etc Reconnect to Oximeter cable to the CHIME monitor 5 E After END study calibration markers and before the cry recording while data is still being saved to the optical disk Disconnect the Oximeter cable from the CHIME monitor Count to 10 one one thousand two one tho
30. e sensor should be placed over the orbit of one eye If the infant is placed in the lateral position then place the sensor on the contralateral side Non allergenic tape should be used to hold the sensor in place and the lead wire should also be taped to the cheek so that strain on the wire will not pull the sensor off the eye cII 69 10 02 95 Connect the sensor cable to the input connector on the electronic box and lock the plug in place by twisting the clip located on the plug near the prongs so that it engages the clip on the socket and keeps the plug from accidentally coming out of the socket Connect the output cable to the output connector on the electronics box and connect the other end of the cable to the input marked EYE MOVEMENT on the CHIME data acquisition unit or SPARE 1 on the Calvin box of the ALICE 3 PSG machine Figure 8 Switch the eye movement sensor box on by flipping the toggle switch to the on position Within a few seconds recordings of eye movement should be seen on the eye channel of the PSG computer CHIME PSG Thermometer This instrument consists of the electronics package itself a thermistor for measuring skin temperature and a thermistor for measuring air temperature The skin temperature thermistor consists of a metal disk at the end of a flexible white wire connected to a longer more robust gray wire with a plug at the other end This plug should be connected to the connector marked SKIN on the front
31. ed into the standard electrical outlet cII 67 10 02 95 This completes the procedure for connecting the D A S unit and computer to the ALICE 3 system It is important to note that the connections between Calvin and the ALICE 3 unit remain the same as they were when the D A S unit was not used ALICE 3 will not work properly if these connections are not correctly made Operating the D A S Computer Although the D A S system is connected between the subject and ALICE 3 it does not interfere with any of the normal ALICE 3 functions with the exception of measuring electrode impedance Thus it is possible to use ALICE 3 without using the D A S computer by merely using the connections described in the previous section and switching the D A S amplifier unit on by means ofthe red switch on the top ofthe unit You will know that the unit is switched on by the light that shines from within the switch The only ALICE 3 function that does not work with the D A S system connected is the measurement of the EEG electrode impedances while collecting data by depressing lt F gt on the ALICE 3 keyboard We had to sacrifice that function to enable the D A S system to collect data not only for ALICE 3 but also for the D A S computer A small electrode impedance meter has been designed at the CTOC to allow electrode impedances to be measured independent of the D A S or ALICE 3 monitor To begin collecting data ALICE 3 should be set up in the usual manner O
32. ed no further attention until the study ends cII 68 10 02 95 Ending a Data Acquisition Session Once the PSG study has been completed you can stop the data acquisition system by pushing the escape lt ESC gt button on the keyboard The blue bar at the bottom of the screen will say interrupted after number scans Save used buffers to disk and below that are listed a highlighted Yes No If the Yes is highlighted and you wish to save the data push the lt Enter gt button If you do not wish to save the data move the highlight to the No using the right arrow key and then push the lt Enter gt key Once this selection is made data acquisition is complete To exit the program you must push the S key to bring up a new menu under the word System at the top of the screen The last item on this menu is Exit and you can either highlight this by pressing the lt Down Arrow gt key five times or typing the letter E Once the exit is highlighted press the lt Enter gt key and you will return to the C prompt Eye Movement Sensor Test Before use the batteries should be tested This is done by depressing the battery test button labeled press to test and holding the button down for at least three seconds The battery test light should come on and remain on for the entire duration of the time the button is depressed If the light comes on as the button is depressed but its intensity decreases and eventually the light goes out while t
33. ed to CHIME Monitor scoring the accuracy of event detection the significance of small chest or abdominal deflections 3 EEG respiratory and cardiac summary variables for the entire study To achieve these goals the protocols described below are to be followed Except for Step 2 scoring will be the responsibility of DCAC 2 Procedures for Scoring AT ALICE STEP 1 QUALITY CONTROL Load the appropriate optical disk and check whether the Infant ID is correct and identifying information complete If not remedy To begin scoring turn ALICE system on When menu appears select ALICE 3 option Please refer to Healthdyne ALICE 3 Manual as needed On Main Menu select View Patient by pressing lt ENTER gt or CLICK on L mouse button when arrow is on View Patient or press V on keyboard From list of saved acquisitions select study to be scored press lt ENTER gt or click L mouse as usual Check box at upper right of screen to be sure you have the study you want If not click R mouse and return to Main Menu and try again cII 44 10 02 95 STEP 2 INITIAL SURVEY AND DCAC COMMUNICATION Step 2 should be performed within three working days of the recording so that subject and personnel can benefit 1 Review the data for clinical events that require immediate attention and or notification of a physician During the night the technician will have flagged these on the comment sheet Each laboratory
34. els Comments will automatically be reprinted on the raw data screen Refer to data acquisition section for abbreviations Table 5B 2 Retrieve the event log from Step 1 for this infant To get a general impression of the recording and to identify periods of wakefulness feeding scan this log When you get to these epochs determine whether you agree with ALICE 3 decisions If baby is awake you can assign a W Also on the report print out note the gestational and post conceptional age so that you know whether to expect certain patterns such as trace alterant or sleep spindles 3 Go to the All Night Screen and select samples of AS QS and Awake that is A W per ALICE scoring Determine whether the EMG varies in level according to sleep states If it does not look further into the record to see if tonic variations are present If there is no variability eliminate this channel from scoring 4 Go to the raw data screen F4 and verify that you are at the first full epoch after the onset calibration Start scoring at the first full minute epoch after calibration 17 00 not 16 59 30 5 Individual parameter codes will be assigned to each epoch between onset and offset calibrations See Appendix B When is a signal good enough to serve as one of the five parameters This must be established by gaining an overview of the recording during the night in particular during A Q and W Fill in X if data is unavailable Irregular
35. encies generally will not be present The following Rules and Procedures are based on the Atlas Task Force EEG Arousals Scoring Rules and Examples Sleep 1992 15 174 184 A copy of this reference is included in the Appendix C PROCEDURE 1 In state scoring montage EEG and EMG displayed examine the EEG for evidence of transient arousals only during quite sleep and indeterminate sleep 2 Ifthe rules are met place the cursor at the beginning of the arousal and drag the mouse to the end of the arousal When you release the mouse a menu screen will be displayed and you may click on appropriate arousal type 3 Each arousal will be classified as a spontaneous arousal SA evoked arousal EA apnea termination AA or clinically significant event technician related arousal TA To determine the type of arousal first switch to Alternate Montage 2 displaying the cardiorespiratory signals for the presence of precipitating respiratory events and then examine the technician notations to determine if there was a precipitating environmental stimulus for the arousal a An evoked arousal is preceded by a change in the environment or is induced by the caretaker or technician b AA An apnea termination arousal begins during or immediately after an apnea or hypopnea gt 4 seconds in duration SA A spontaneous arousal has no discernable precipitating stimulus d TA Arousals induced by caretaker or technician stimulation r
36. eparation and Acquisition Checklist VII 9 4 Electrodes and Supplies Required VII 13 5A Items to be Entered on ALICE3 F 1 VII 35 5B Infant Behaviors Annotation VII 36 6 Codes to States VII 49 Figures 1 Electrode placement Respiband placement VII 14 2 Connecting Respiband to Patient Cable VII 14 3 Standard International 10 20 Scalp Electrode Placement Sites VII 18 4 EOG and EMG Electrode Placement VII 21 5 Head Wrap Illustration VII 22 6 Pulse Oximeter Placement VII 24 7 Calvin Input Device VII 25 8 Healthdyne Thermistor Placement VII 26 9 Healthdyne Patient Box Inputs VII 28 10 Respiration Rate in ALICE3 VII 48 11 Events Table VII 56 cII 3 10 02 95 A Environment and Equipment Requirements 1 Equipment A Healthdyne ALICE 3 system currently version 1 17 will be used for the laboratory polysomnographic recordings The basic reference is the ALICE 3 System Software User s Manual Adult Infant Acquisitions 1994 edition This system which consists of a 486 33 IBM computer and 20 monitor also includes a a HP LaserJet IIIP Printer b 800 mB optical disk drive and one or more disk drives Such as a 3 5 high density floppy disk drive ALICE 3 requires interfacing with an amplifier signal processor unit CALVIN and special input device It includes infant software to analyze cardiorespiratory EEG and sleep state data In order to raise sampling rates and allow for adequate storage an additional 486 computer Gateway 2000
37. equired for the resolution of a clinically significant prolonged cardiorespiratory event 4 Scored arousals will appear on the final ALICE event log 5 Arousal examples in Appendix 61 53 10 02 95 RULES In order to be considered an arousal the following criteria must be met 1 10 second period of sleep must precede an arousal Disregard the arousals that do not meet the duration criteria of gt 3 seconds you can round up from gt 2 5 seconds 2 The minimum duration of time between arousals should be 10 seconds These examples below clarify the use of this criterion a 1 4 second arousal 12 seconds quiet 4 seconds arousal 2 arousals 4 second arousal 3 seconds quiet 4 seconds arousal 1 arousal 3 4 second arousal 1 second quiet 4 seconds arousal 1 arousal b 1 2 second arousal 12 seconds quiet 4 second arousal 1 arousal 2 2 second arousal 4 seconds quiet 4 second arousal 1 arousal Note This assumed 4 seconds of quiet EEG preceding the 2 second arousal 3 2 second arousal 1 second quiet 4 second arousal 1 arousal Note This assumed 4 seconds of quiet EEG preceding the 2 second arousal 3 During quiet sleep Q or IS an arousal may occur in the absence of an increase in EMG amplitude 4 If movement artifact delta waves or signal blocking occur within an arousal these are included in meeting the duration criteria Blocking must be clearly accompanied by a preceding i
38. escoring a new scoring summary should be printed out AT CHIME MONITOR BASE STATION 6 ALICE 3 event utilize the CHIME scoring software to add the results of ALICE 3 scoring to the corresponding CHIME event Note that there are special fields in the CHIME Monitor software that allow input of the results of the ALICE 3 scoring Also note that it is possible that a genuine event scored on ALICE 3 may have been labeled FALSE on original CHIME Monitor scoring In these cases the ALICE 3 fields should still be added 7 Ifan ALICE 3 event was not detected by the CHIME Monitor use CHIME Monitor software to add the event to the CHIME database 8 Print out new CHIME Monitor scoring summary 61 66 10 02 95 Appendix A Several components of the data acquisition protocol are in the final stages of testing these include the DAS thermometer and eye movement sensor Descriptions of these components are in this appendix for information purposes only When the components are ready to be integrated into the acquisition procedure an addendum to this PSG protocol with implementation details will be distributed to each site CHIME PSG Data Acquisition System The CHIME Data Acquisition System requires different connections between study subjects and the ALJCE 3 PSG monitor than would be used for a straight ALICE 3 PSG The principal difference is the use of the D A S amplifier as the interface between the subject and the electronic equip
39. f steps to be followed a CHIME PSG Thermometer preparation See Appendix A II 8 10 02 95 0 0 00 OO TABLE 3 PSG PREPARATION AND ACQUISITION CHECKLIST The Begin Study data calibration must begin no later than 2100 hours therefore preparation should commence by 1900 1930 hours Have baby brought to lab at 1830 1900 hours Prior to infant arrival do the following a Lay out all electrodes supplies equipment including extra baby diapers etc b Have backup CHIME Monitor and CHIME supplies ready Getoutall forms this checklist H2 Visit H5 F1 Channel Checklist Optical Disk Log and Cry Log Set up Nellcor or monitor as needed Have CHIME PSG and home cartridge as well as the optical disk ready for use Connect all components to ALICE 3 Turn ALICE3 on and check range values Check audio video equipment emergency box and notification routine Prepare other site specific forms logs as needed Synchronize time clocks as needed e Infant arrival a Collect H 5 from caregiver do Form D if necessary b Check CHIME Monitor and condition of electrodes c Remove home cartridge out of the CHIME Monitor and replace it with the PSG cartridge Do not turn monitor on until baby is quiet and you are ready to check waveforms 5 minutes of quiet recording is required to set monitor baselines Enter patient information on ALICE3 and estimate begi
40. givers have left the infant room the recording can begin Allow a half hour to an hour for channel and baby adjustments If the quality of one of the signals is poor limited re application can be contemplated at this time The art and skill of overnight polysomnography in infants pivots on the adequacy of the initial application This should be done thoroughly quietly and without unduly upsetting the baby Rushing through it is not advisable even with a late start because a shortened recording of high quality is more valuable than a long one with deteriorating signals Although the infant cannot be asked to perform the maneuvers requested of older children and adults the signal quality can be assessed by observing spontaneously occurring behaviors When the child is awake there should be a good quality signal with the left and right EOG of opposite polarity If the eye movements are recorded but are of the same polarity check the position of the electrodes Be sure there is a good quality chin EMG signal that increases during crying or sucking Adjust the gain check electrode position and or plug in a different pair of EMG electrode leads until a good quality signal is reached If ECG artifact is present in the EMG channel choose a different pair of electrodes to select the signal If active REM s observed prior to the begin calibration that is during AS adjust the gain on the chin EMG so minimal tonic muscle activity is recorded the sig
41. he button is still depressed there is not enough power in the battery to operate the sensor for the PSG and the batteries need to be replaced If the light does not come on at all once the button is depressed the batteries need to be replaced Battery lifetime is approximately 90 hours for fresh batteries Thus you can expect to change batteries after seven 12 hour PSG studies If the batteries need to be replaced follow the instructions in the replacement of batteries section of these instructions Note Replacement of Batteries The following steps should be used in replacing the battery AA any brand 1 Unscrew the four screws in the corners of the front panel of the CHIME eye movement sensor electronic box 2 Lift the front panel from the box recognizing that it is connected to the batteries by two wires careful not to break these wires 3 Remove the old batteries from the battery clip noting their orientation Replace these batteries with fresh batteries in the same orientation is indicated on each side of the battery clip to show the orientation of the positive battery terminal Make sure that the batteries are firmly installed in the battery holder 4 Re assemble the front panel on the box You might want to press the battery test button to make sure that the light lights before replacing the screws in the four corners on the front panel This completes the battery replacement procedure Eye Movement Sensor Th
42. he same for all infants Buffers should display the following values 75 30 400 25 0 1 and 3 Continuous Record should be set to ON check mark ALARM RECORD Event Waveforms Buffers APNEA 90 16 Pre Record sec 75 25 25 Post Record sec 30 Labored Breath 9 0 9 0 Calibration Values Rapid Breath 240 240 Def Quan Val 400 BRADYCARDIA 80 80 44 wks PCA Min Acc Vol 25 60 60 244 wks PCA Periodic Recording Tachycardia 240 240 Starting Hour 0 O Sat 50 50 Interval hours 1 Duration minutes 3 Continuous Record ON ON Check Mark OFF No Check Mark 5 Note Monitor will ALARM for Band and Lead Disconnects and asystole slow heart light gII 77 Quality of Individual PSG Channels Infant s Name Study ID Date Quality of Individual PSG Channels CHANNELS GAIN SET BOX ALICE COMMENTS AMPLITUDE IMPEDANCE IMPEDANCE R EOG Cl ee qeu s 4 dem p o fom os e fom 101010402 a o p s Es mmm diw S e po feo 00 2 emen ma ___ ES de ama 0 2 5 fom s s fon __ com Thermistor II 78 10 02 95 Oximeter Pulse Waveform w osmo _ 00 00 m wes 0 S S cII 79 10 02 95 REFERENCES ALICE3 Manual of Operations 1994 version Anders T The infant sleep profile 1974 Neuropadiatre 5 425 44
43. ightly delayed Any significant decrease in amplitude may indicate a concomitant decrease in SaO reliability When the pulse signal identifies unreliable data the SaO signal must be eliminated for that segment and 5 seconds beyond Using the mouse position the cursor arrow on the left most area of the bad pulse signal Depress and hold the left button on the mouse Move the mouse a small distance to the right so a narrow segment of the screen approximately 1 mm is defined by two parallel narrow black lines running from top to bottom Release the button on the mouse The area between the two lines will be black and a menu will appear on the left side ofthe screen Use the mouse to select Start Highlight Period by moving the cursor to this block on the menu and pressing the left button on the mouse one time Now the menu and the highlighted area disappear and a green box comes up in the lower margin of the screen that says highlight time Move the cursor arrow to the end of the bad area and highlight one millimeter area as before When the menu appears select End highlight period The green box at the bottom of the screen now shows the time for the beginning and end of the bad area Now move the cursor arrow to the left margin of the screen and position it over the title SaO Click on right mouse button ESC On drop down menu select ADD FAIL PERIOD You should see a grey bar cover the period you selected cII 64 10 02 95 Elimination
44. ill be very few instances during the carefully monitored and supervised overnight polysomnographic recordings when clinical interventions will be indicated The baby will be on the CHIME Monitor the continuous mode If an apnea greater than 20 seconds in duration occurs it is advisable to look at the SaO and heart rate If a downward trend is evident go look at the baby refraining from stimulating her him until SaO desaturation lt 85 for gt 30 seconds or b Heart rate lt 60 bpm for at least 10 seconds EMERGENCY INTERVENTION 1 Ifbaby is having a significant clinical event as described above stimulate the baby by flicking the heels 2 Ifthe significant clinical event continues make sure airway is patent reposition and suction if needed and bag baby with a few puffs of O2 3 Ifthe perfusion and do not return to previous levels continue to bag baby and call appropriate code for physician 4 If seizure activity is noted rather than tremors verify the EEG Check for cyanosis and airway patency Provide supplemental to maintain saturation at pre seizure level Page the appropriate physician cII 43 10 02 95 F PSG SCORING 1 Introduction to Scoring Scoring protocols are designed to describe 1 Sleep and waking states 2 Several aspects related to event occurrences including a characteristics of events that occurred during the overnight PSG study b ALICE PSG event scoring as compar
45. le level ALICE 3 Left and right leads should be placed adjacent to the CHIME monitor leads at the side of slightly above but not touching The AL CE 3 ground snap electrode will be placed on the left abdomen just above the level of the AB respiband If the baby comes from home with Jenson electrodes already in place and they look clean and intact they can be left on and used for the PSG If there is any question of their adequacy replace them Respiration Effort Always use new respibands even if the baby has new ones on when he she arrives for the PSG Use 15 or 24 bands as appropriate for the size of the baby Place the top respiband around the ribcage RC at the level of the nipples slightly above so as not to irritate the nipple and the bottom band around the abdomen AB at the level of the umbilicus see Figure 1 for starting positions Fold the loose ends of the bands over the baby to meet at the midline Press the bands firmly together so they are snug but do not impede breathing Snap the CHIME monitor RC cable connectors to the end of the top ribcage band and the AB cable connectors to the bottom band Figure 2 Be sure there are no gaps between baby and the velcro snap end In order to prevent sliding on the skin the bands can be secured with a band aid Temperature See Appendix A Sites will be notified when and how to use this equipment when it is made available to the sites EEG Seven Grass gold cup electrodes
46. ment as opposed to the Calvin unit that is used when the ALICE 3 monitor is used alone The D A S amplifier is connected to the Calvin by means of a cable that connects between the input device connector on the Calvin unit and the Calvin connector on the back of the D A S amplifier The auxiliary input connectors on the side of the Calvin unit labeled 1 2 3 4 5 get connected to the five connectors labeled aux immediately under the Calvin connector on the D A S amplifier Please note that the numbering of these connectors on the D A S amplifier is not sequential and it is important that the small telephone wire connection be made between connectors of the same number on the Calvin unit and on the D A S amplifier unit Special cables with small black plastic connectors on each end are provided with the D A S unit to connect the eye movement and temperature channels between the D A S amplifiers and Calvin Connect one end of the one cable to the connector labeled Spare 1 on Calvin and the other end to the connector on the back of the D A S unit labeled eye out Similarly connect the second cable to the connector labeled Spare 2 on Calvin with the other end connected to the connector on the D A S amplifier unit labeled temp out This completes connecting the D A S to the Calvin unit Connecting the D A S Amplifier Unit to the Patient The patient box normally connected to the input device connector on Calvin is now connected to
47. mination of Monitoring 21 Site Assessment of PSG Quality 22 DCAC Assessment of PSG Quality 23 Cry Recording E Protocol for Emergency Intervention during PSG F PSG Scoring 1 Introduction to Scoring 2 Procedures step 1 QUALITY CONTROL step2 INITIAL SURVEY AND DCAC COMMUNICATIONS step3 INITIAL ALICE REPORT step 4 Sleep Wake State Scoring step5 Transient Arousal Scoring Rules and Procedure step 6 Score Apnea Events gt 10 Seconds step 7 Scoring of Hypopnea step 8 Artifact removal 1 2 CO 3 ECG step 9 Final Report ALICE step 10 Comparison of ALICE 3 and CHIME Monitor events Appendix A CHIME PSG Data Acquisition System Eye Movement Sensor CHIME PSG Thermometer Appendix B Table of Contents CHIME Monitor PSG Cartridge Parameters Quality of Individual PSG Channels Forms F1 Example of Instructions to Parents State Coding Parameter Summary 5 1 95 ALICE 3 Waveform Scoring Examples DCAC PSG Quality Review Form References Appendix C Reprint EEG Arousals Scoring Rules and Examples Appendix D Approved Sensor List 2 VII 34 VII 38 VII 38 VII 38 VII 39 VII 40 VII 41 VII 42 VII 43 VII 43 VII 43 VII 44 VII 45 VII 45 11 51 VII 53 VII 60 VII 62 VII 63 VII 63 VII 65 VII 67 VII 68 VII 71 VII 74 VII 75 VII 77 82 VII 84 VII 85 VII 117 VII 118 VII 119 VII 125 10 02 95 List of Tables and Figures Tables 1 PSG Montage VII 5 2 Infant Sleep Lab VII 6 3 PSG Pr
48. n and end acquisition times e View waveforms and go to calibration to set filters and check impedances Use jumper cables to eliminate ECG artifacts if necessary f Adjust and reapply sensors as needed to get impedances lt 10K ohms and clean waveforms Type final impedances on AL CES3 screen at study initiation g Setend acquisition to allow 8 hours post 2100 plus enough time for post calibration time check and Cry if ordered Remember AL CE3 cannot do more than 10 hours total h It should be no later than 2030 at this point If all is well start oximeter time check process calibrations and then begin study Type Begin Study on AL CE3 directly after end of Calibrations Enter interventions feeding diaper changes temperature and humidity on Form F1 j During PSG recording annotate all behaviors of the infant and staff which may impact on the PSG recording See Section 16 Chart Annotation Do not forget to comment at least every 5 minutes especially during sleep note eyes closed EC DO NOT USE ANY UNDEFINED ABBREVIATIONS PLEASE cII 9 10 02 95 END OF STUDY CHECKLIST 1 If you set the stop acquisition time for say 0530 then you must be prepared to do the oximeter time routine 1 minute of calibrations and up to 5 minutes for the Cry before 0530 If Begin Study occurred prior to 2100 hours and you want to end after 8 hours but before the stop time you entered you can but remember to do time check calibrations
49. nal should not be totally removed since some muscle activity will then be lost The near isoelectric EMG tracing can then be used to make amplitude comparisons between states During the recording periodic checks should be made to ensure that no change to artifact amplitude has occurred Observe the baby s breathing and be sure that synchronous breathing is reflected in synchronous chest wall and abdominal signals If the chest wall and abdomen appear to be out of phase on ALICE 3 be sure that the child s breathing is out of phase on inspection Move the baby s foot that is connected to the actimeter to be sure that motion can be detected Since there is no gain adjustment on this channel if the signal is unsatisfactory the actimeter must be reapplied Test Signal Transfer to DAS See Appendix A 60 31 10 02 95 Synchronization of time clocks between ALICE 3 computer and CHIME monitor By synchronizing the ALICE 3 computer and the CHIME monitor events recognized by one system can be compared with events recognized by the other system Both systems record events based on the time of day they occur This time is derived from each of the computer system s clock However the CHIME monitor clock may not be set at the TRUE time of day This is mainly due to the fact that all CHIME monitor clocks are set to local standard time and are not updated when Daylight Savings goes into effect AL CE 3 computer clocks should always by checked prior to th
50. nce it has been determined that ALICE 3 is collecting the data as desired by the investigators the D A S computer can be started This is done by first switching on the computer and waiting until the C prompt C V appears To start the program type das and push the lt Enter gt key A blue screen should appear that says Global Lab At this point type the letter S followed by the enter key and a small menu will appear at the center ofthe top ofthe screen From this menu choose A D Module by moving the highlighted band using the down arrow cursor key or typing the letter A We are now in the data acquisition mode of the software and a new window will appear at the upper left corner of the screen Choose the entry on this menu labeled Load and a menu that asks you to type in the name ofthe set up program for the PSG will appear At this point you should type in CHIME followed by the lt ENTER gt key and this will load the CHIME montage for the data acquisition system Once this is completed the small window in the upper left hand corner of the screen will reappear Now it is necessary to name the file where the data will be stored on the computer s hard disk Select the Edit item from the menu and a new large complicated window will appear At the lower right hand corner of this window is an entry called Filename A name which is usually CHIME OUT will appear at this point and you should use the mouse to position the cursor small white ar
51. ncrease in EMG amplitude 5 Isolated sleep state or stage transitions are not scored as arousals 6 Although transient arousals have an end point by definition there is no specific termination criterion and duration of arousals is not scored If the arousal proceeds to an awake state the arousal ends at the point the infant is no longer asleep 61 54 10 02 95 STEP 6 SCORE APNEA EVENTS 2 10 SECONDS NOTE ALICE 3 provides a tally of central mixed and obstructive apnea which require verification and possibly additions and deletions DEFINITIONS Central apnea Absence of airflow in the and thermistor channels lasting gt 10 seconds and accompanied by an absence of chest and abdominal respiratory efforts Obstructive apnea Absence of airflow in the and thermistor channels lasting gt 10 seconds with continued ribcage and abdominal respiratory efforts Mixed apnea Absence of airflow in the and thermistor channels lasting gt 10 seconds with both central and obstructive components manifest in the ribcage and abdominal channels The central and obstructive components must each last at least 3 seconds 61 55 10 02 95 PROCEDURES 1 Retrieve the ALICE 3 event report and identify all events 210 seconds An event that occurs during sleep even ifthe epoch is scored as wakefulness should be considered as an event 2 Using Alternate Montage 2 follow ALICE 3 procedures to view each 30 second epoch f
52. nsor Affix the double sided tape on the back of the Healthdyne nasal oral thermistor Press the sticky side under the nose so that the tips are in front of but not touching the nares and mouth It may be necessary to carefully bend the tips slightly away from the brown strip See Figure 7 Actimeter With actimeter connected to CALVIN shake it gently to establish that it is operational Black boxes rectangles should appear on the ALICE3 screen during acquisition mode if it is working If not use alternate Repeat process Place the Healthdyne actimeter on the bottom of the right foot and secure with tape LEOG REOG Prepare the sites with alcohol or Omniprep Use Contour IB snap or gold cup electrodes and place LEOG 0 5 cm above and 0 5 cm away from the outer canthus of the left eye REOG is placed 0 5 cm down and 0 5 cm away from the outer canthus of the right eye Direct lead wires away from the face and into the pony tail See Figure 4 cII 24 10 02 95 Probe is placed on left foot with red light source on top of foot Tape to foot so that the detector is on the bottom of the foot opposite the light source PULSE OXIMETER PLACEMENT FIGURE 6 II 25 10 02 95 Understanding CALVIN The illustration below shows a top view of the cover plate The red LED light provides various indications a continuous steady light indicates that the unit is powered on and is ready for signal acquisition a slow flashing light indicates data is
53. nt Record Label in last name field first name date of birth sex and gestational age Press ENTER to move from one field to the next see box below 6 In comment section enter infant s assigned group i e comparison SIDS SIB ALTE and impedances Event Record Label 21 CHARACTERS MAX First name 21 CHARACTERS MAX Date of birth 12 12 92 Sex F Gestational age 40 NOTE If you Comments 21 CHARACTERS MAX make an error continue to enter 21 CHARACTERS MAX until you have completed all Acquisition start time 00 00 fields You will Acquisition stop time 06 00 10 02 95 have an opportunity to correct any mistakes before leaving this screen gII 12 10 02 95 6 Polygraphic recording preparation The polygraphic recording should contain the information requested on the ALICE 3 screen as illustrated in 5a ALICE 3 screen at study initiation will be added here when software is available on ALICE 3 cII 13 10 02 95 7 Application of Electrodes Directions are presented in the optimal order of application Table 4 summarizes the necessary array of electrodes by placement site Extra sensors must be available in case last minute replacements are required This is particularly important for specialized sensors such as the Healthdyne thermistor and actimeter See Appendix D for a listing of approved sensors BODY Q HEAD 4 ELECTRODES AND SUPPLIES REQUIRED
54. o be considered Each laboratory should have a log book in which details about the infant and the polysomnographic session can be entered A loose leaf folder can be designated for each infant in which all relevant information is contained The infant s Study ID is critical because all information will be filed under this number It is important to review procedures with the parents and to offer explanations Parents can be invited to watch or hold the child as needed Much of the skin preparation and attachment of electrodes can be done while the baby is bottle fed In some laboratories the mother caregiver will be permitted to stay throughout the night but few elect to do so exceptions are those who prefer to breast feed the baby In some laboratories one parent or caregiver is required to stay with the baby to help with caregiving A maternal sleeping room should be made available so that unnecessary awakenings are prevented Prior to preparing the study infant for monitoring the Post Enrollment Medical Follow up Form Form D should be completed if one has not been completed in the past 2 weeks Ifthe infant has been home a study monitor technicians should collect the Alarm Log Form H5 from caregivers A CHIME POLYSOMNOGRAPHY CHECKLIST Form F1 See Appendix B should be initiated at this time and items completed as the calibrations and sleep study progress Refer to Table 3 PSG Preparation and Acquisition Checklist as a reminder o
55. ome lukewarm water and prepare the infant for return to the nursery or departure with the parents Apprise parents of any redness or rashes that have been observed and how to take care of these On the Form F1 note any special circumstances especially adverse reactions to paste tape or heat on the infant s skin Study personnel should also complete an H2 Visit form to document how the CHIME monitor functioned throughout the PSG On Form H2 Visit under Type of Contact check PSG Comparison Before the CHIME monitor is returned to the caregivers for home use replace the PSG cartridge with a newly initialized cartridge in the event mode and give caregivers a new Alarm Log Form H5 to take home Enter both cartridge serial numbers on the H2 Visit form If the monitor was found to malfunction during the PSG a replacement should go home with caregivers Site Assessment of PSG Quality The designated CHIME Study PSG Reviewer is responsible for maintaining the quality ofthe PSGs from thatsite As soon as possible this person should review each PSG recording and should complete page 5 of the CHIME POLYSOMNOGRAPHY CHECKLIST Form F1 The primary aim is to identify and immediately resolve problems to insure improved subsequent recordings Any information should be reviewed with the PSG technicians who performed the recording so that appropriate changes and modifications will be made The completed page 5 should be forwarded to DCAC for inclusion with the
56. onitor positioned in the sleep room can be started This event recording system will be used at its preset record settings for the duration of the polysomnographic recording cII 28 10 02 95 10 02 95 cII 30 10 02 95 10 11 12 13 Positioning Infant The electrode array does not permit monitoring in the prone position Babies should be laid supine or their backs may be propped slightly with a clean rolled up blanket or towel Infants under one month of age should be swaddled while mittens or arm restraints may be used in older infants You are now ready to begin the acquisition Never plug in or unplug PC Calvin phone jack if AL CE is on Environmental Conditions Covering of the infant depends on room temperatures Efforts should be made to maintain room temperatures between 22 and 24 degrees centigrade when a thermostat is available choose the 23 degree setting Ambient light should be comparable among centers but control of ambient noise can probably not be assured Unexpected noises such as sirens must be annotated on the chart A nightlight not exceeding 40 watts should remain on in the infant room Infants will be dressed in a dry disposable diaper 2 tog units one piece sleeper 2 tog units and covered with 2 flannel blankets 3 4 tog units Assessing Signal Quality The signals should be stored on ALICE while you are performing these tasks The light should be dimmed and when personnel and parents care
57. or your selected infant beginning after the onset calibration at the first full minute on the minute and concluding with the last full 30 second before the end calibration Since there will be a minimum of 8 hours of recording you will be scanning at least 960 epochs Your objective is to evaluate the apnea flagged by ALICE 3 and identify any missed ones You may wish to do these two tasks separately or simultaneously Alternate Montage 2 consists of ECG cardiotachometer ribcage abdomen sum VT CO2 THERM nasal oral airflow pulse waveform O saturation and actimeter 3 If an apnea gt 10 seconds central mixed or obstructive apnea is present in a certain 30 second epoch you first measure the duration If you consider the duration incorrect modify the ALICE 3 record by inserting the correct duration Rules for these and other decisions are outlined in Rules Page VII 58 If you do not agree about the presence of an apnea you remove the flagged apnea from the ALICE 3 event table If you remove an event because one or more ofthe respiratory traces are obscured by movement or artifact add the notation uninterpretable U to the comments 4 Youthen proceed to get additional information about the accepted apnea which is to be entered in DCAC data matrix Is it central obstructive or mixed The time the event began time of peak measurement began What was the sleep state when the apnea occurred A Q IS W Du
58. ore or an arousal confirmed by EEG See Arousal Protocol Step 5 Obstructive hypopnea OH partial obstruction A 50 decrease in the amplitude of the thermistor signal lasting 10 seconds or more with ribcage and abdominal movements partially or completely out of phase In order to qualify one of two additional criteria must be fulfilled the event must be accompanied by a drop in SaO of 4 or more or an arousal confirmed on EEG See Arousal Protocol Step 5 PROCEDURES AND DECISION MAKING RULES 1 Choose Alternate Montage 2 which consists of ECG cardiotachometer ribcage and abdominal movements sum VT CO THERM pulse waveform and actimeter 2 Retrieve the ALICE 3 event log ALICE 3 will identify hypopnea based on drops in THERM of 50 or more The objective is to verify these drops and to determine whether either one or both of the other two criteria are present as well If not the event should be deleted Hypopneic events fulfilling the criteria that ALICE 3 failed to identify are to be added a Begin by scrutinizing each flagged hypopnea Verify the 4 drop in SaO In order to accept the validity of the SaO signal there should be at least 3 acceptable pulse waves Ifartifact prevails this latter criterion is not fulfilled and the SaO cannot be used to accept or reject the hypopnea The SaO drop should occur either during the hypopneic event or within seconds after the termination of this event Check whether a pre
59. panel of the instrument directly beneath the digital display Make sure that the connector is pressed all the way into the socket so that good contact is established The air thermistor is located within a metallic cylindrical cage with oval openings on the sides It also has a gray wire with a plug on the end that should be connected to the socket on the electronic instrument front panel marked AIR The output signal from this instrument is available at the smaller connector marked OUT on the right hand side of the front panel A special cable that connects between this connector and the CHIME data acquisition amplifier unit is provided with the instrument One end ofthis cable should be plugged into the connector marked OUT and the other goes to the data acquisition amplifier to the connector marked TEMPERATURE IN The CHIME PSG thermometer is operated on battery power and does not require any other connections for power or information transfer Since it is battery powered it is important that the power switch is left in the off position when the thermometer is not used so that battery energy can be conserved Instructions for Use with PSG The following steps should be carried out in using the thermometer for PSG studies 1 Make sure that the thermistors and interface cables are connected as described above 2 skin thermistor should be placed on the infant s abdomen in the right upper quadrant over the liver See Section D 6 j
60. pirations and body movements is likely to be in active sleep or awake A brief period of another state often indeterminant interrupting an ongoing period ofa given sleep state by 30 seconds one epoch should be scored the same as the surrounding epochs cII 49 10 02 95 Put cursor on peak of shortest cycle 1 and click L button holding down button drag mouse cursor to next peak Read CPM value in box at upper left screen Repeat for longest cycle Ifthe cpm values differ by 20 then code as I and if less and 20 code as R 25 8 42 9 25 3 cpm 42 9 cpm RESPIRATION RATE IN ALICE 3 FIGURE 10 ARTIFACTS a Disruptions or artifactual signals of 15 seconds or less duration may be present within an epoch Ignore them and code the clean part of the tracing Movement artifact X gt an epoch but lt 2 epochs can be smoothed over if previous and subsequent states are the same Continue the surrounding state through the ones with artifact For example WXW must be changed to WWW If the states are different code the variables for that portion of the following state that is readable If artifacts last more than 2 epochs score all epochs as awake If movement results in a state transition code the part of the movement that can be read b Examples of specific artifacts are in Appendix B cII 50 10 02 95 TABLE 6 Codes to States Individual Parameters Q QS EEG H T M EOG EMG Resp R BM Mouthing Sucking EEG F
61. r In summary 1 Annotate caregiving periods by typing BEGIN followed by a description of the caregiving activity and when the caregiving is completed type END These periods will be designated as Awake 2 Annotate Interventions by typing IN followed by a description of the intervention and when the intervention is completed type OUT These periods may still be assigned an infant sleep state 3 If you are unsure whether an activity is an Intervention or a Caregiving period use the codes for Interventions and then describe the intervention Guidelines for Re application of Electrodes During PSG Recording Electrodes may get dislodged Since sleep and wakefulness are target variables awakenings for electrode re application should be the exception For the purpose of this study an infant should only be awakened if the the ECG or SaO tracings have been lost No effort should be made to re apply the EEG and EMG electrodes since such re application will almost certainly arouse the infant and preclude undisturbed sleep During spontaneous awakenings for feeding the eye movement sensor the nasal oral thermistor or other sensors can be readjusted if necessary After diaper changes remember to retape the position sensor to the back of the diaper cII 35 10 02 95 TABLE 5A ITEMS TO BE ENTERED ON ALICE3 AND ON THE PSG CHECKLIST F1 FORM PLEASE ENTER INFORMATION ASSOCIATED WITH THE TOPICS LISTED BELOW INTO ALICE AND ON
62. ration to whole second of entire apnea and duration of central portion if a mixed apnea If the apnea precipitated see Rules a significant desaturation SaO lt 90 identify the lowest desaturation value on Form F2 in low SaO field Verify that event precipitated arousals AA or TA were identified Rules about arousals can be found in Step 5 PSG AROUSAL SCORING Is the apnea preceded by a sigh Enter sigh Y N II 56 10 02 95 10 02 95 EVENTS TABLE FIGURE 11 cII 58 10 02 95 OPERATING INSTRUCTIONS cII 59 10 02 95 RULES Central Apnea Refer to the definition above The most artifact resistant channel is the therefore use this as your primary reference to identify the breaths preceding and following the airflow cessation The duration of apnea should be measured from the end of inspiration to the end of the next inspiration peak to peak If there is a discrepancy between duration and THERM duration use the channel that gives the shortest apnea duration for determining the beginning and end point of the apnea Now consult the abdominal channel and verify whether there was a simultaneous cessation in respiratory movements Ifthe answer is yes the apnea can be considered central NOTE 1 NOTE 2 NOTE 3 NOTE 4 NOTE 5 NOTE 6 NOTE 7 NOTE 8 NOTE 9 Cardiogenic Artifacts can be frequently observed in the CO signal In order not to confuse these with breaths check
63. re those that are most important to sleep state and respiratory scoring If a signal is deemed unscorable for the majority of the night a comment is made as to the reason for the signal being unscorable 23 24 Annotations Awake periods must be clearly marked Likewise movements should also be clearly annotated 25 Filter Settings These are determined from the data in the user event table and should be the same as those already listed 26 Calibrations EEG and EMG calibrations are the ALICE calibrations that designate the beginning and end calibration times for the PSG The NIMS calibration are the times that the CHIME monitor was synchronized with ALICE 27 20 Indicate whether PSG documentation material was received at the time the PSG was reviewed 30 31 Indicate whether all the data from the PSG was retrievable from the optical disk If a problem with restoring the data occurs a description ofthe problem and a request for additional information or for the site to resubmit the data may be made 32 Overall comments These are general comments concerning the DCAC review of the PSG gII 41 10 02 95 23 Cry Recording All study infants will have a cry session at the conclusion of the PSG with the sensors still on the infant and the ALICE 3 still on Refer to Manual of Operations section VIII Cry Protocol cII 42 10 02 95 E Protocol for Emergency Intervention during PSG EMERGENCY PROCEDURE DURING POLYSOMNOGRAPHY There w
64. respiration in preterms will make many epochs I for irregular and hence Indeterminate Sleep IS Keep that information rather than force the epoch into quiet sleep Parameter codes are in Table 6 and in parameter scoring section that follows Parameter scoring a EM Determine if one or more REMs occur in the epoch If a REM is present code as otherwise b EEG Check the frequency of the EEG by clicking mouse and manually counting the number of cycles and reading the Hz cycles per second Always look at C4 A unless it is obscured or not otherwise available Identify EEG pattern that occupies gt the epoch and select the EEG code for that pattern Use CHIME single letter codes not those in Anders et al Use the 50 rule If an cII 48 10 02 95 g epoch has gt 50 of a pattern the epoch is assigned that pattern Patterns have been defined as H gt 50 microvolts and F as lt 35 microvolts and M mixed is a combination of H and F Differentiate between eye movements in the EEG and true HVS activity EMG Determine EMG tonic level plus or minus If level does not vary do not include EMG in the scoring and score based on four or three parameters Use the 50 rule If an epoch has gt 50 of a pattern the epoch is assigned that pattern RESPIRATION Measure airflow regularity using method in Figure 10 Respiratory disturbances pauses periodic breathing pauses scorable apnea hypopnea are discounted when considering
65. rest of the PSG documentation cII 40 10 02 95 22 DCAC Assessment of PSG Quality The DCAC has implemented a standard review process for all PSGs The results of the review are summarized on DCAC PSG QUALITY REVIEW FORM See Appendix B A copy of this review is included with each disk that is returned from the DCAC to the CHIME site The purpose of this form is to document the PSG quality and to provide feedback to each site concerning the quality of the PSG as compared to PSGs collected from all other sites PSG personnel at the site should review this form If there are any questions or comments concerning the results of this review these should be discussed first with the local CHIME PSG REVIEWER and if necessary then contact the DCAC for further clarification DCAC PSG QUALITY REVIEW FORM A summary of the qualities of the PSG signals in respect to any problems that may have occurred during the PSG recording session will be documented on the DCAC PSG QUALITY REVIEW FORM The header region of the form summarizes information relating to the site Study ID PSG date optical transmittal disk and who completed the PSG review Subsequent sections 1 22 Signal quality summarized each channel of data A subjective determination is made as to whether the signals are of sufficient quality to be used for scoring purposes In general the quality of the signal must be adequate for at least 2 3 66 of the night Channels that are highlighted a
66. row at the C and press the left mouse button Now you can type the name of the storage file so that it replaces the CHIME OUT in that listing The conventions for naming the CHIME storage file follows After you have typed in the filename move the cursor with the mouse to the button labeled OK and depress the left mouse button The screen will return to the small window in the upper left hand corner Now choose the acquisition mode by typing A A new small window will appear under the word Acquisition at the top ofthe screen The first item in this menu is the word Go and it should be highlighted in white If for some reason it is not highlighted use the up or down arrow curser keys to move the highlighted area to the word Go To start acquisition push the Enter key and the data acquisition screen will appear This consists of a series of 20 horizontal white lines on a black background To actually start acquiring data you must push any key on the keyboard and you will see the waveforms being collected on the screen These signals will be flashing by too fast to be able to be viewed and understood but this display can be used to indicate that data is being collected At the bottom of the screen will be a blue bar with the words Acquisition Running If you do not see this the acquisition system is probably not running correctly and you need to repeat the previous steps to make sure that data is being acquired The D A S computer ne
67. rts for adults and 10 available reports for infants some reports have multiple pages Each report type is listed below Select the starred reports and file Recording Identification Information Technical settings Signal Quality Analysis Sleep Data adult studies 3 pages infant studies 1 page Respiratory Events adult and infant studies 3 pages Heart Rate Summary pH Summary infant studies only Oxymetry Summary adults and infant studies 2 pages CPAP Report adult studies only Miscellaneous results Snoring and Myoclonus Summaries adult studies only Allnight Screen Event List STEP 4 SLEEP WAKE STATE STAGE SCORING Note Study sites will not be responsible for completing Steps 5 9 They are included for documentation purposes only DEFINITIONS Sleep state wake coding will follow the guidelines of Anders Emde Parmelee 1971 This method will be applied to infants through one month of age as well as older infants Some centers will also follow the sleep stage scoring guidelines of Rechtschaffen and Kales 1968 in infants gt 3 months of age PCA cII 47 10 02 95 PROCEDURES 1 Select scoring Alternate Montage 1 must include EEG C3 Mo O1 M2 gt LEOG REOG and or EM EMG ECG abdominal respiration airflow waveform SaO waveform and actimeter NOTE Look at ECG to screen for arrhythmias and to be able to correlate the R waves with artifacts in other chann
68. t Note the distance in cm With the tape in place find the point that is half the ear to ear distance and mark the intersection with your nasion inion CZ mark With the tape still in place measure up 10 from the preauricular point on each side of the head T3 and T4 in Figure 3 then measure 20 up from T3 and mark C3 measure 20 up from T4 to mark C4 Measure the circumference of the head by placing the tape along the 10 markings all the way around Note half the distance and then calculate 10 of this distance Mark 10 to the left and right of FPZ these points are FP1 and FP2 Direct the tape through FP1 back to the 10 marks on the left side of the inion at the circumference line Mark the intersection This intersection is 01 Repeat this process on right side from FP2 to locate 02 M1 and M2 are the left and right mastoid respectively Palpate the bone behind the ear and avoid any blood vessels to reduce ECG artifact Abrade sites with Omniprep or similar substance on cotton tip applicator Fill the gold cup with paste and press firmly to prepared site Hold in place 10 20 seconds cover with gauze or cotton ball Be sure cable lead wire is directed away from face toward back Repeat for each site When all are placed check impedances on ALICE 3 impedance screen All values should be less than 10K ohms green or yellow lines Lead wires should be secured in a pony tail with all the other face and head wires 61 18 10 02 95
69. tage 40 W Adjustable Lamp TEMPERATURE 1 Ambient 23 C BED 1 Infant Crib INFANT SUPPLIES 1 Diapers 2 Shirts 3 Blankets 4 Pacifiers 5 Suction Bulb 6 Formula Breast Milk 7 1 Piece Sleeper ASSOCIATED EQUIPMENT 1 Sink 2 Scale 3 O2 4 Suction INFANT SLEEP ROOM 1 Video Camera 2 Monitor 3 CHIME Monitor 4 Carpeting EQUIPMENT MONITORING ROOM 1 ALICE 3 Monitoring System 2 Video Monitor Recorder 3 Telephone CHIME BACKUP MONITOR EMERGENCY CART TRAY II 6 10 02 95 C Scheduling 1 Healthy Term Infants When a Healthy Term infant is enrolled the DCAC will inform the site at what age to performa PSG Apnea of Infancy Infants Apnea of Infancy subjects should be scheduled within two weeks of study intake Preterm Infants Preterm infants should be scheduled to have a PSG within two weeks of study intake Siblings of SIDS Infants Subsequent siblings should be scheduled to have a PSG at 1 month of age Surviving twins of SIDS victims receive a PSG which should be scheduled as soon as possible after the death of their twin D General PSG Procedures 1 Preparation of the Laboratory It is critical that the laboratory is surveyed at the completion of a recording and prepared for the next recording The polysomnographic equipment should be left in good operating condition Monitoring personnel should maintain an equipment log See example in Appendix B so that engineers can identify
70. te drops precipitously due to a loose electrode or an artifact for at least 3 beats remove the signal Healthdyne will consider adding median heart rate values which protects against isolated erroneous data STEP 9 UPON COMPLETION OF ALICE 3 SCORING PRINT OUT FINAL SUMMARY REPORT STEP 10 COMPARISON OF ALICE 3 and CHIME MONITOR EVENTS The CHIME DCAC will be responsible for comparing the scored events from both the ALICE 3 system and the CHIME Monitor Study sites will not be responsible for completing the following items They are included here for documentation purposes only cII 65 10 02 95 Standard Event Scoring also see Step 6 and Step 7 1 Obtain the summaries of the results of scoring of events for both ALICE 3 and CHIME Monitor 2 For each event scored on ALICE 3 that meets the CHIME criteria determine if there was a corresponding CHIME Monitor event that occurred during the same period AT ALICE 3 3 Based on CHIME Monitor scoring summary use ALICE 3 to review all events that included low amplitude deflections 4 Locate each event and evaluate the airflow signals to determine the presence or absence of airflow for each low amplitude deflection Note the total number of low amplitude deflections with airflow 5 If any events were scored as genuine on CHIME Monitor scoring but not identified during ALICE 3 scoring these should be located on ALICE 3 and rescored to accurately characterize the events Following r
71. tented facial expression Yawning Wide open mouth with prolonged inhalation MO Mouthing Repetitive open and closing of the mouth SUCK Sucking Periodic sucking movement of mouth and lips SIGH Sigh Long deep audible exhalation PACIFIER USE BPAC Begin Pacifier The infant has begun using a pacifier EPAC End Pacifier The infant has ended the use of a pacifier VOCALIZATIONS BCRY Begin Cry Beginning of a crying period ECRY End Cry End of a crying period VOC Other vocalizations Sounds produced by the infant including those listed below Whimpers Low whining broken cry sounds Babbling Incoherent vocal sounds Grunting Short deep hoarse sounds II 37 10 02 95 Hiccough Sharp quick sound caused in involuntary contraction of diaphragm ANNOTATE ALL OTHER BEHAVIORS BY TYPING IN A DESCRIPTION OF THE BEHAVIOR REFER TO TABLE 5A FOR ADDITIONAL INFORMATION CONCERNING TECHNICAL DATA AND ENVIRONMENTAL CONDITIONS THAT SHOULD ALSO BE ANNOTATED cII 38 10 02 95 18 Nurse Technical Caregiver Interventions Routine infant care will be continued during the PSG Nurses technicians can help mothers breast feed their infants at the crib bedside without substantially affecting the quality of the recording Infants should always be burped well prior to resumption of sleep Other interventions should be restricted to those predicated on the severity of physiological patterns i e only for resuscitation See E Protocol for Emergency Intervention
72. that BUBBLES are introduced in to the cavity d Remove the round backing paper for the adhesive washer and place the electrode on the prepared skin surface e Press the electrode down firmly to attach and seal the electrode to the skin 3 Cleaning the electrodes after each use a Remove the main bulk of the gel with a cotton swab b Use distilled or deionized water to wash out remaining gel inside the cavity NEVER USE TAP WATER Soak electrode in a container with mild saline solution until the next application d Do not allow the old gel to dry or harden in the cavity Please annotate on Alice you may type in G electrodes when you use the GEREONICS EMG electrodes Doing so will allow the PSG reviewer to know when these electrodes are being used After application of EEG and EMG electrodes check impedances with the AL CE3 and if available the Cleveland impedance meter and note them down on Form F1 Be prepared to enter these values later onto the AL CE3 screen at study initiation To check impedance and get a better idea of how good your connections are press lt F10 gt The screen will provide a color coded graphic representation of the top of the patient s head with the selected montage indicated cII 20 10 02 95 COLOR COMMENT IMPEDANCE green good signal lt 5K ohms yellowwarning watch the electrode there may be a problem 5 10K ohms red bad signal poor connection recheck the electrode gt
73. the ECG frequency and ignore those waves that coincide with the heartbeats or SaO pulse waveform Also the THERM may give you a clue to the first real breath or resumption of breathing after an apnea A more accurate estimate of apnea duration is obtained by measuring the interval between the end of inspiration and the next onset of inspiration Healthdyne uses this interval in their ALICE 3 algorithm For the human eye peak to peak detection is easier and this strategy is selected for the CHIME Monitor tracing and incorporated in this protocol as well As a result the duration values may have to be altered for each apnea There is almost one second lag between the CO signal and other respiratory signals The term simultaneous presupposes that you discount that 1 second delay In some circumstances only the THERM will be available You can use this channel as an alternative to CO The beginning and end of the apnea must be timed on the same channel Ifthe preceding or subsequent breath is broad without a peak identify the middle of that breath as the peak If breaths are more easily identified on the THERM channel time the apnea using this channel The first breath or few breaths following a central apnea may be paradoxical with reduced airflow However the central apnea terminates at the first effort even if the breath 1s out of phase The first breath following a central apnea may be paradoxical without airflow obstructed breath
74. the connector labeled patient box on the D A S amplifier unit The cable from the NIMS monitor that normally is connected to Calvin through a special set of wires that went into the auxiliary input is now connected to the D A S unit at the connector labeled NIMS A special cable has been provided with the D A S unit to connect the output from your capnometer to the input connector on the D A S labeled CO in Similarly a cable from the special CHIME eye movement sensor connects to the connector on the D A S amplifier labeled eye in The special CHIME temperature monitor connects through its cable to the input labeled temp in The patient box and the capnometer eye movement sensor and temperature monitor are all connected to the study subject in the same way as is done with the ALICE 3 Connecting the D A S Amplifier Unit to the D A S Computer The D A S amplifier unit has an output connector labeled D A S and this gets connected to the D A S computer by means of a cable provided with the D A S unit The cable connects to the unmarked connector on the back of the computer near the right when facing the back of the computer This is the only connector on the computer that will accept the D A S cable so do not try to force the cable into another connector on the computer where it will not fit properly The D A S amplifier must also be connected to the power supply using the connector labeled 12 VDC and the power supply is plugg
75. usand etc Reconnect to Oximeter cable to the CHIME monitor Count to 10 one one thousand two one thousand etc Disconnect to Oximeter cable from the CHIME monitor Count to 10 one one thousand two one thousand etc Reconnect to Oximeter cable to the CHIME monitor P aes COINS 61 32 10 02 95 The technician will verify that each step of the synchronization procedure is completed on the CHIME POLYSOMNOGRAPHY CHECKLIST 1 cII 33 10 02 95 15 16 Calibration When you are satisfied with the quality of the signals calibrate for 1 full minute beginning on the minute The onset of calibration marks the onset of computer analysis for the CHIME protocol From this time onward the computer can not be turned off until the completion of the end calibration Please note the warning above EEG and EMG signals should not be reapplied and calibration should not be undertaken in the middle of recording A calibration signal of 100 microvolts can be displayed for the EOG EEG EMG and ECG channels Press lt F9 gt at the Raw Data screen and you will be transferred to the Calibration Signals screen to see this signal Since you must know the amplitude of the EEG signals this screen will indicate whether the internal amplifiers are working correctly and responding equally to the 100 microvolt signal Check all EEG channels to make sure they are identical in appearance You should access the Calibration Signals screen
76. ve electrolyte gel and 200 adhesive collars washers washers Order standard male jacks Gel from Gereonics is Sigma Gel Parker Respiration Effort Respiband Plus Bands 24 set of two or 15 set of two Model 107 007 24 or 107 007 15 Respiration Airflow Healthdyne neonatal nasal Healthdyne thermistor thermistor with supply of double stick adhesives catalog No 6210 Contour S30 1B Conductive Contour solid gel ECG neonatal pediatric Medical Technology Inc disposable Ag AgCl electrodes 45 pouch Jenson Premie Solid Gel Cloth Snap Ag AgCl Reusable Electrodes P N A 3501 30 pouch P N A 3502 or P N A 3503 Jenson Medical International Ohmeda SoftProbe Reusable Ohmeda 7900 222 F 61 125 10 02 95 General Skin Preparation Omniprep 5oz Tape Micropore Tape Transpore Tape Coban Cotton Tipped Applicators 100 6 inch CO Salter Labs No 4701F Infant Divided Cannula Oxygen delivery sampling nasal cannula Bandage Kerlix Disposable single pt use Kendall Conform Stretch Bandage 2 or 4 X 4 1 yd stretched Kling elastic gauge Optical disks Maxtor OC 800 or equivalent Arm Restraints Pediwrap w o thumbhole 201 neonatal or pediatric 203 Posey Oximeter Probe Wrap 6554 gII 126 Salter Labs City Computer amp Supply The Medi Kid Co These should be available through your medical center purchasing or centr
77. viously scored arousal is contingent on this event An arousal is considered contingent if it occurs during or within 5 seconds after the termination of the hypopneic event If at least one of the two or both criteria is not fulfilled remove the flagged hypopnea from the ALICE 3 event table by marking it with a minus sign Hypopnea related arousals during AS A will need to be identified during hypopnea scoring as they are not included in sleep state scoring b Ifyou agree with the ALICE 3 decision measure the duration If you disagree with the value in the table rectify by inserting the correct value The beginning of an hypopneic event is defined by the cII 62 10 02 95 peak of the last full breath that is the breath before the amplitude dropped by 50 The termination of an hypopneic event is defined as the peak of the first breath with an amplitude 250 Then consult the ribcage and abdominal channels to determine if it is central or obstructive hypopnea If these two channels are in phase it is a central hypopnea A will confirm that you agree the event is a central hypopnea If these two channels are not in phase it is an obstructive hypopnea This can be scored as a user defined event Use the sign to remove the central hypopnea Sweep the cursor across the event When you release the mouse button the menu of both ALICE 3 and user defined event will appear Click on obstructive hypopnea and the event will be added to the event
78. yet this obstructed component may not last the 3 seconds necessary to meet criteria for mixed apnea The termination of central apnea is timed with the return of respiratory efforts Both the CO and airflow channels are subject to displacement artifact They also have different time lags or offsets from the respiratory effort channel The beginning and end of apneas must be timed on the same channel and you are to use the channel that gives you the shortest apnea duration If both the and THERM are displaced examine the respiratory effort channels for any cessation of effort 2 10 seconds In this instance you may use the RC or AB channels to score central apneas based on time from peak of last effort to peak of first effort on the same channel cII 60 10 02 95 Note the different strategy for identifying peak to peak inspiration on the channel vs the respiratory effort and thermistor channels cII 61 10 02 95 STEP 7 SCORING OF HYPOPNEA This protocol utilizes the same ALICE 3 event log and the ALICE 3 procedures that are used to verify and characterize apneic events 10 seconds See Step 6 DEFINITIONS Central hypopnea CH A 50 decrease in the amplitude of the thermistor channel lasting 10 seconds or more with the ribcage and abdominal movements in phase In order to qualify one of two additional criteria have to be fulfilled the event must be followed by a drop in oxyhemoglobin saturation SaO of 4 or m

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