Clinical trial NCT02707003: Clinical Utility of Capnography in the PACU( Post-anaesthesia Care Unit)
Official title: A Multi-Center Pilot Observational Trial to Quantify the Potential Clinical Utility of Capnography in the PACU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Depression
Keywords: Post-operative respiratory distress
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults booked for a surgical procedure that meet the I/E criteria and willing to provide consent for observation in the PACU and chart review 24 hours post PACU discharge.

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of Respiratory Adverse Events in the PACU identified by capnography
timeFrame: Up to 2 hours in the PACU
Secondary outcomes:
measure: Frequency of Critical Adverse Events (CRAE)
timeFrame: PACU and 24 hours post PACU
measure: Ventilation insufficiency on transfer from the PACU
timeFrame: At PACU discharge
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Banner University Medical Center
name: Peter R Lichtenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Francis F Chung, MBBS FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung F, Wong J, Mestek ML, Niebel KH, Lichtenthal P. Characterization of respiratory compromise and the potential clinical utility of capnography in the post-anesthesia care unit: a blinded observational trial. J Clin Monit Comput. 2020 Jun;34(3):541-551. doi: 10.1007/s10877-019-00333-9. Epub 2019 Jun 7.