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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZ PACU | Observation of standard of care with capnography blinded | ||
| TWH PACU | Observation of standard of care with capnography blinded |
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| 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:
| Up to 2 hours in the PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Critical Adverse Events (CRAE) | Critical CRAE in the PACU or in 24 hour post PACU chart review:
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter R Lichtenthal, MD | Banner University Medical Center | Principal Investigator |
| Francis F Chung, MBBS FRCPC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85724-5114 | United States | ||
| Toronto Western Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38843498 | Derived | 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. | |
| 31175500 | 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. |
| Label | URL |
|---|---|
| Post Study Publication | View source |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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 |
| Toronto |
| Ontario |
| M5T 2S8 |
| Canada |