Clinical Utility of Capnography in the PACU( Post-anaesthesia Care Unit)

NCT02707003 | Completed

• 1 other identifier: COVMOPO0526
• Study Type: observational
• Target: 250
• Locations: 2 countries
• Sites: 2

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)

Conditions

Respiratory Depression

Keywords

Post-operative respiratory distress

Outcome Measures

Primary Outcomes (1)

• Frequency of Respiratory Adverse Events in the PACU identified by capnography

  Identification by blinded capnography to understand the ventilation challenges of patient in the PACU during standard of care that does not include capnography. First tier is RN (Registered Nurse) level of notification for early intervention and second tier is level at which covering MD (Medical Doctor) might request notification: 1. High Respiration Rate \>25 bpm for \> 15 seconds (tier one) and \>30 bpm for more than 30 seconds (tier two) 2. Low Respiration Rate \< 8 bpm for more than 15 seconds and \< 6 bpm for more than 30 seconds 3. High end tidal CO2 (EtCO2) \> 55 mmHg for \> 15 seconds and \> 60 mmHg for more than 30 seconds 4. Low EtCO2 \< 25 mmHg for \> 15 seconds and \< 25 mmHg for more than 30 seconds 5. High Heart Rate \> 120/min for 15 seconds and \>120/min for 30 seconds 6. Low Heart Rate \< 40/min for 15 seconds and \< 40/min for 30 seconds 7. SpO2 (oxygen saturation by pulse oximetry) /Hypoxemia \< 90% for more than 15 seconds and\< 90% for more than 30 seconds

  Up to 2 hours in the PACU

Secondary Outcomes (2)

• Frequency of Critical Adverse Events (CRAE)

  PACU and 24 hours post PACU

• Ventilation insufficiency on transfer from the PACU

  At PACU discharge

Study Arms (2)

AZ PACU

Observation of standard of care with capnography blinded

TWH PACU

Observation of standard of care with capnography blinded

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult ≥ 18 years of age
• ASA Score II - IV (American Society of Anaesthesiologists Score)
• Patients booked for a surgical procedure requiring general anesthesia care
• Expected duration of general anesthesia to be \> 1.5 hours
• Expected to receive intraoperative opioids
• Expected to be transferred to the PACU from the operating room
• Patients with an expected duration in the PACU ≥ 45 minutes
• Expected to be transferred from the PACU to an in-patient setting

You may not qualify if:

• Patients expected to be discharged from the hospital when discharged from the PACU
• Subjects who will have oral/nasal surgery that may prevent wearing an oral/nasal capnography sampling filterline.
• Subjects with a history of severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors.
• Patients with skin lesions or physical deformities that would prevent the application of finger sensors for optimal performance.
• A female known to be pregnant.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Banner University Medical Center

Tucson, Arizona, 85724-5114, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (2)

• Kanaparthi A, Chung F, Lichtenthal PR, Sprung J, Weingarten TN. PRODIGY score predicts respiratory depression in the post-anesthesia care unit: A post-hoc analysis. Biomol Biomed. 2024 Oct 17;24(6):1662-1668. doi: 10.17305/bb.2024.10585.

  PMID: 38843498 DERIVED

• 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.

  PMID: 31175500 DERIVED

Related Links

• Post Study Publication

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Peter R Lichtenthal, MD

  Banner University Medical Center

  PRINCIPAL INVESTIGATOR

• Francis F Chung, MBBS FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 11, 2016
• Study Start: February 1, 2016
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2018
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)