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| Name | Class |
|---|---|
| King Abdullah International Medical Research Center | OTHER |
| McMaster University | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Awake Proning | Experimental | The oxygen mask or NIPPV or HFNC will be initiated at the treating team's discretion. The patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating oxygen mask or NIPPV or HFNC treatment. Once the patient achieves the above parameters within 15 minutes of initiating oxygen therapy through any modality, the healthcare team will start awake proning. |
|
| Control - Standard of Care | No Intervention | The patient will receive usual care without proning at the discretion of the treating team. The oxygen mask or NIPPV or HFNC will be initiated, the choice of starting oxygen mask versus NIPPV versus HFNC will be up to the treating team, the patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating NIPPV or HFNC treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Awake Proning | Procedure | The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endotracheal intubation | Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth. | within 30 days of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death | 60 days |
| Invasive mechanical ventilation free days | Number of days not receiving mechanical ventilation | censored at 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
Immediate need for intubation as determined by the treating team.
Decreased level of consciousness (Glasgow Coma Scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)
Contraindication to proning including, but not limited to any of the following:
Open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, Unstable spine, facial, cervical, femur, or pelvic fractures. Limited neck mobility or inability to lie prone comfortably Skeletal deformities that interfere with proning. Complete bowel obstruction. Active upper gastrointestinal bleeding. Patient is unlikely/unable to prone, or to be compliant as indicated by the treating team.
Body mass index > 40 kg/m2
Pregnancy - third trimester.
Patient/substitute decision maker or caring physician's refusal to enroll in the study.
Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)
Intubation is not within patient's goals of care
Patient received awake proning session for > 1 day prior to randomization
Previous intubation within the same hospital admission
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| Name | Affiliation | Role |
|---|---|---|
| Waleed Alhazzani | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Yaseen Arabi | King Saud Bin Abdulaziz University for Health Sciences | Principal Investigator |
| Zainab Alduhailib | King Faisal Specialist Hospital and Research Center, Jeddah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Sciences Centre | Dallas | Texas | 77030 | United States | ||
| Univeristy of Calgary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35569448 | Derived | Alhazzani W, Parhar KKS, Weatherald J, Al Duhailib Z, Alshahrani M, Al-Fares A, Buabbas S, Cherian SV, Munshi L, Fan E, Al-Hameed F, Chalabi J, Rahmatullah AA, Duan E, Tsang JLY, Lewis K, Lauzier F, Centofanti J, Rochwerg B, Culgin S, Nelson K, Abdukahil SA, Fiest KM, Stelfox HT, Tlayjeh H, Meade MO, Perri D, Solverson K, Niven DJ, Lim R, Moller MH, Belley-Cote E, Thabane L, Tamim H, Cook DJ, Arabi YM; COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group. Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2104-2113. doi: 10.1001/jama.2022.7993. | |
| 33555780 |
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A multicenter, parallel-group randomized controlled trial
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| Non-invasive ventilation free days | Number of days not receiving non-invasive mechanical ventilation | censored 30 days |
| Days alive and outside ICU | Number of days alive and outside the ICU | 60 Days |
| Days alive and outside of hospital | Number of days alive and outside of hospital | 60 days |
| Complications from proning, | Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other. | 30 days |
| Calgary |
| Alberta |
| Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Hamilton General Hospital | Hamilton | Ontario | Canada |
| Juravinski Hospital | Hamilton | Ontario | Canada |
| St. Catharine's General - | St. Catharines | Ontario | Canada |
| Sinai Health System | Toronto | Ontario | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | Canada |
| CHU de Québec - Université Laval | Québec | Canada |
| Al-Amir Hospital | Kuwait City | Kuwait |
| Jaber Al Ahmed hospital | Kuwait City | Kuwait |
| King Fahad Hospital of the University | Khobar | Eastern Province | Saudi Arabia |
| Prince Mohammed bin Abdulaziz Hospital | Al Madīnah | Saudi Arabia |
| King Abdulaziz Hospital - NGHA | AlAhsa | Saudi Arabia |
| King Abdulaziz Medical City - Jeddah | Jeddah | Saudi Arabia |
| King Abdulaziz Medical City | Riyadh | Saudi Arabia |
| King Faisal Specialist Hospital & Research Center | Riyadh | Saudi Arabia |
| Derived |
| Alhazzani W, Evans L, Alshamsi F, Moller MH, Ostermann M, Prescott HC, Arabi YM, Loeb M, Ng Gong M, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Machado F, Wunsch H, Crowther M, Cecconi M, Koh Y, Burry L, Chertow DS, Szczeklik W, Belley-Cote E, Greco M, Bala M, Zarychanski R, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Nainan Myatra S, Arrington A, Kleinpell R, Citerio G, Lewis K, Bridges E, Memish ZA, Hammond N, Hayden FG, Alshahrani M, Al Duhailib Z, Martin GS, Kaplan LJ, Coopersmith CM, Antonelli M, Rhodes A. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update. Crit Care Med. 2021 Mar 1;49(3):e219-e234. doi: 10.1097/CCM.0000000000004899. |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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