Clinical Utility of Capnography in the PACU( Post-anaesthesia Care Unit)
Status: | Completed |
---|---|
Conditions: | Depression, Pulmonary |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/29/2018 |
Start Date: | February 2016 |
End Date: | June 15, 2018 |
A Multi-Center Pilot Observational Trial to Quantify the Potential Clinical Utility of Capnography in the PACU
Multi-center observational trial with study device blinded in order to assess in parallel
standard monitoring and intervention practices related to management of respiratory
compromise in the post-anaesthesia care unit (PACU)
standard monitoring and intervention practices related to management of respiratory
compromise in the post-anaesthesia care unit (PACU)
All Study device information is blinded to medical staff but the Study Coordinator will have
full access to device measurements, alarms, notification and events via a local Wi-Fi hub
sent to a portable tablet. The tablet Case Report Form (CRF) will allow all observation be
inserted with a time stamp on the electronic device data. In addition, all electronic data
will be collected from the bedside monitor.
full access to device measurements, alarms, notification and events via a local Wi-Fi hub
sent to a portable tablet. The tablet Case Report Form (CRF) will allow all observation be
inserted with a time stamp on the electronic device data. In addition, all electronic data
will be collected from the bedside monitor.
Inclusion Criteria:
1. Adult ≥ 18 years of age
2. ASA Score II - IV (American Society of Anaesthesiologists Score)
3. Patients booked for a surgical procedure requiring general anesthesia care
4. Expected duration of general anesthesia to be > 1.5 hours
5. Expected to receive intraoperative opioids
6. Expected to be transferred to the PACU from the operating room
7. Patients with an expected duration in the PACU ≥ 45 minutes
8. Expected to be transferred from the PACU to an in-patient setting
Exclusion Criteria:
1. Patients expected to be discharged from the hospital when discharged from the PACU
2. Subjects who will have oral/nasal surgery that may prevent wearing an oral/nasal
capnography sampling filterline.
3. Subjects with a history of severe contact allergies that may cause a reaction to
standard adhesive materials found in pulse oximetry sensors.
4. Patients with skin lesions or physical deformities that would prevent the application
of finger sensors for optimal performance.
5. A female known to be pregnant.
We found this trial at
2
sites
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