This protocol was created by Jinhee Park on 6/27/2011 and modified for the purposes of this study by Britt Pados on 10/10/2012.
Prior to Arriving at Infant’s Bedside:
• Check everything that belongs on the feeding cart (use the checklist).
• Turn on the Lenovo computer and select ‘computer only log on’ (enter ID and password). • Turn on the BioNex Chassis and all the equipment and open the BioLab 3.0.10 icon. • Open the BioLab 3.0.10.
• Open the configuration file (Diss_config_file.mwcfg) that was previously set up and saved in the D issertation folder on the desktop.
• Check the settings of the equipment according to the Protocol for Preparation of the Data Collecti on Cart.
• Check the settings of the configuration window:
68 Channel setting
69 Audio/Video Setting
Trending setting
• Exit the BioLab program.
• Shut down the all equipment and computer.
• Disconnect the pulse oximeter sensor, transducer, respiration band, ECG leads, and microphone from the equipment and put them back into the first drawer.
70 At the Infant’s Bedside:
• Make environment is as quiet as possible (Pull the curtain down, Dim the lights, etc.) • Connect the cables to the BioNex Chassis and to the equipment
• Turn the computer on (The receiver of wireless mouse must be unplugged from the USB port bef ore you turn on the computer).
• Turn on the power of the BioNex Chassis and all equipment (Pulse oximeter, Microphone, ECG, Ambu Sleepmate, and camera)
• Open BioLab 3.0.6.
• Open the configuration file (Diss_config_file.mwcfg) that previously set up and saved in the Disse rtation folder on the desktop.
• Put sensors on the baby
Pulse oximeter: Place pulse oximeter sensor on the infant’s left foot and secure with additional placement wrap.
ECG: place electrodes on the infant’s chest as below. Note. Do not remove the infant’s own electrodes if he/she has them, but you can move them if needed.
Skin conductance ECG: Place electrodes on the infant’s foot and ankle as shown below.
Respiration: Place respiratory band around the infant’s chest at nipple level on the top of the infant’s clothes.
Microphone: Place the mic on the infant’s mid neck at the suprasternal notch with double-side d tape and secure with a hydrogel tape.
• Make sure the signals are all good before the infant is settled. • Let all instruments warm up 30 min
Baseline data collection:
• Begin to record after completion of the feeding prior to the first study feeding (When recording, you can see green light on the right bottom)
Click AQUIRE on the bottom of the configuration window • Enter the random, 5-digit subject ID in Britt’s dissertation folder
• Hit START/STOP button on the upper left of the BioLab acquisition screen to start recording. • Video camera should be collecting a picture of the infant’s entire body. Hit record button on the
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• Send the analog out calibration signals from the Masimo to the BioNex Chassis.
Pulse wave: Hit menu , select ‘output’, and set ‘Analog 1’ to ‘0V Signal’. Verify that the Bio Lab shows a voltage of approximately 0V on pulse wave channel. Set ‘Analog 1’ to ‘1V Signal ’ and then verify that the BioLab shows a voltage of approximately 1V on pulse wave channel. Hit menu , select ‘output’, and set ‘Analog 2’ to ‘0V Signal’. Verify that that the BioLab sho ws an approximately 0% of Sp02 on the second channel. Set ‘Analog 2’ to ‘1V Signal’ and then verify that the BioLab shows approximately 100% of Sp02 on the second channel. • Continue to record until the infant wakes for the feeding after data collection is complete.
• Monitor the quality of data signals in each channel. If the signal is lost or has too much noise, PI should be informed.
Pulse wave & EKG
Normal EKG signal: regular R-R interval
It usually comes with regular pulse wave form.
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If the signal goes flat or has irregular waveform for few seconds, report this to PI.
SaO2: The signals on the Masimo and the BioLab need to be corresponding to each othe r. Note: The alarm of the Masimo will be indicated only by the symbol of alarm flashing. Please let PI know if alarm is flashing.
Swallowing
Respiration
Data collection during feeding:
• When the infant wakes up for feeding, routine nursery care will be provided by his/her assigned nurse or parent.
• Weigh infant in clothing and diaper in which he/she will be fed. • Swaddle the infant.
• Proceed with feeding according to predetermined feeding order. Video camera angle will need to be adjusted for feeding position to capture the infant from the waist up.
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• When feeding is determined to be finished, record the length of feeding time. • Weigh infant in same clothing and diaper as prior to feeding.
• Post feeding nursery care will be provided by nurse and/or parent and infant will be placed supine in crib or held by family member. Pacifier may be offered as necessary.
Data collection after feeding
• All equipment is to remain on the infant and the physiologic data collection continues.
• The video camera should be repositioned to capture the infant’s entire body in the crib and video recording begun.
After Data collection
• Shut down all equipment, computer, and BioNex Chassis. • Gently remove all monitoring equipment.
• Wipe down all cables and monitoring equipment as it is put away from the baby and put it back int o the drawer in the physiologic cart. Note: Put the equipment that requires cleaning into the zip ba g (e.g., microphone, resp. band).
• Wash bottle and nipple used for study according to unit standard of practice. • Clean up all the equipment or throw away if it is disposable.
<Pulse oximeter sensor and cable> Wash the light blue band.
Wipe down the black band and the crystal sensor with alcohol swab or disinfectant wipes. <Respiration band>
Wash the light blue band.
Wipe down the black band and the crystal sensor with alcohol swab or disinfectant wipes. <Others>
Wipe down other equipment with alcohol swab or disinfectant wipes.
• Back up the data on an encrypted, password-protected external hard drive and lock in filing cabi net.
• Download the trend data from the Masimo Radical-7 pulse co-oximeter.
Assure that the Radical-7 serial output mode is set to “ASCII2” (MENU <OUPUT) Open Trendcom software on the computer.
Under the ‘instrument’ menu in Trendcom, select ‘Radical-7 (V7619 or greater)’. Under the ‘COM Port’ menu, select ‘COM5’.
Click on ‘Retrieve Trend’. The following message may appear: “please make sure the Radical is set to ASCII2 output mode” and click OK.
Name the file.
Save the file to the appropriate folder.
You will have date, time, Sp02, pulse rate and perfusion index (PI) every 2 seconds that is s ame as averaging rate you set.
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• Download the video files from the Panasonic HDC-TM700 if you need a high resolution AVCHD vi deo file.
Assure that HD Writer AE 2.1 is installed in the computer. Connect the video camera to the computer with the USB cable. Turn the video camera on.
Open HD Writer AE 2.1.
Click ‘Copy to PC’< ‘Video Camera (E)’< ‘Next’. Select the video file what you want to download. Assign the folder and name the file.
Click ‘Execute’.
• After downloading the video files, format built-in memory on the Panasonic camera MENU<SETUP<FORMAT MEDIA<BUILT-IN MEMORY.