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

Use our guide to learn which trials are right for you!

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)

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.

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
Toronto, Ontario
?
mi
from
Toronto,
Click here to add this to my saved trials
Tucson, Arizona 85742
Phone: 520-626-1077
?
mi
from
Tucson, AZ
Click here to add this to my saved trials