Childhood Adenotonsillectomy Trial

6.4 Training and PSG Certification - Field Sites

6.4.1 PSG Technician Certification

The PRC requires the PSG technician to obtain protocol certification prior to performing actual data collection. PSG certification is awarded upon (1) demonstration that the technician has basic understanding and application of specific sensors and equipment to be used for the CHAT PSG acquisition, and (2) demonstrated compliance with the study protocol for data collection, and (3) demonstration of appropriate data transmittal via ftp to PRC including removal of identifier information.

In order to obtain PSG certification the following items must be met:

• Attendance at Central Training or training under the close supervision of a centrally trained PSG technician or designee appointed by the PRC CP.
• Submission of a written exam.
• Adherence to standard placement of electrodes and sensors, including placement of the ground and reference electrodes, as per the CHAT PSG manual of procedures.
• Submission of 2 acceptable overnight (non-subject) PSG recordings performed at the clinical site using the designated CHAT equipment and recording protocol. This serves both as part of the tech certification and as practical experience in using the equipment in the study environment. Certification studies also allow for verification that all sensors and equipment are functioning properly before being used on a study participant.
• De-identifying per protocol and placed on PRC FTP server.

To be considered acceptable the recording must:

• Have good quality signal on each channel (i.e.: all electrodes must work) and signals must be relatively free from artifact.
• Reflect CHAT PSG protocol and procedure and must include:
  • Correct study identification as a certification recording using the following format when naming the recording: CR[TechID]_[date of study mmddyr] CR1002_120507. The electronic recording file must be accompanied with paperwork that matches this naming convention and additionally includes the technician identification and an identifier for the research bed where the test was performed.
  • Impedance check
  • Documentation (paper log or printed electronic log) of events, including physio-cals, impedance measurement values, tech comments and signal checks throughout the recording.
  • Completed Signal Verification (SV) and Signal Evaluation (SE) forms or electronically generated equivalents.

6.4.2 Certification Maintenance

Once certified, maintenance recordings will not be required. If an individual PSG tech submits 3 consecutive CHAT PSGs that have a quality grade of less than “good” then that tech must re-certify with 1 acceptable certification study performed under the direct supervision of the CHAT training tech at that site.

6.4.3 Certification of PSG Acquisition Instrument

• Completion of one Equipment Survey for each identified CHAT PSG unit (minimum of 2 units per site).
• Ability to standardize each identified unit to the CHAT PSG Standardizations.
• Capability to interface with electrodes, sensors and auxiliary devices specified in the CHAT PSG Standardizations.
• Approvable signal quality (as deemed by PRC)
• Ability to de-identify previously recorded patient info and assign a given ID to the PSG file.
• Submission of a sample tracing converted to EDF for each identified CHAT PSG unit to be sent prior to central training. This converted EDF file must use the CHAT PSG Standardized collection and display montages but need not use the auxiliary equipment specified for CHAT if another equipment provides the specified signal. This means that another oximeter, Inductance Plethysmography system with SUM output, and/or end-tidal capnograph used in routine clinical PSG may be interchanged for those specified in CHAT protocol, providing that signal is present, for EDF sample files. This will allow each site to submit EDF samples before waiting for specific equipment to be ordered and interfaced.
• Along with the sample EDF submissions the site must send a minimum of 5 sample pages from the same recording prior to EDF conversion. 1 page must illustrate machine calibration and reflect the standardized calibration display montage. All other pages must reflect the standardized PSG display montage. 1 page should capture epoch 1 of the recording, 1 page should capture the last epoch of the recording and 2 other pages should be chosen randomly but show a waveform event that can be easily located and compared to the EDF file. An example of such an event would be a large K complex, sleep with arousal, unusual artifact, etc. The paper sample pages must clearly show epoch number and clock time.
• Equipment certifications recordings should be named: EQ[IDof unit]_[date of study mmddyy] EQ103_120507