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

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)

Study Overview

• Status: Completed
• Conditions: Respiratory Depression

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724-5114
      • Banner University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AZ PACU; Observation of standard of care with capnography blinded
TWH PACU; Observation of standard of care with capnography blinded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: High Respiration Rate >25 bpm for > 15 seconds (tier one) and >30 bpm for more than 30 seconds (tier two); Low Respiration Rate < 8 bpm for more than 15 seconds and < 6 bpm for more than 30 seconds; High end tidal CO2 (EtCO2) > 55 mmHg for > 15 seconds and > 60 mmHg for more than 30 seconds; Low EtCO2 < 25 mmHg for > 15 seconds and < 25 mmHg for more than 30 seconds; High Heart Rate > 120/min for 15 seconds and >120/min for 30 seconds; Low Heart Rate < 40/min for 15 seconds and < 40/min for 30 seconds; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Critical Adverse Events (CRAE)	Critical CRAE in the PACU or in 24 hour post PACU chart review: Narcotic overdose that required an Opioid reversal; Partial airway obstruction that required an NMBA (neuromuscular blocking agent) antagonist; Respiratory Insufficiency that would require Non-invasive positive pressure ventilation, ambu bag mask assisted ventilation; Respiratory failure that would Invasive mechanical ventilation; Upper airway obstruction requiring airway support measures (oral or nasal) such as intubation, LMA (laryngeal mask airway), or airway; Respiratory insufficiency/failure that would require a transfer to the ICU; Cardiopulmonary arrest; Death due to respiratory/pulmonary related complications Other (free text that might capture aspiration, pneumothorax)	PACU and 24 hours post PACU
Ventilation insufficiency on transfer from the PACU	Population of patients leaving the PACU in early stage ventilation respiratory insufficiency as defined as etCO2 ≤ 25 mmHg or etCO2 ≥55 mmHg combined with low RR (respiratory rate) and hypotension within 15 minutes before transport out of the PACU.	At PACU discharge

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Peter R Lichtenthal, MD, Banner University Medical Center; Principal Investigator: Francis F Chung, MBBS FRCPC, University Health Network, Toronto

Publications and helpful links

General Publications

• 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.

Helpful Links

• Post Study Publication

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): June 15, 2017
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Post-operative respiratory distress
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: COVMOPO0526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: Yes