Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
NCT ID: NCT04350723
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2020-06-10
2021-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention - Awake Proning
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.
Awake Proning
The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
Control - Standard of Care
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.
No interventions assigned to this group
Interventions
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Awake Proning
The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
Eligibility Criteria
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Inclusion Criteria
2. Suspected or confirmed COVID-19. Defined as: a positive PCR for SARS CoV-2 or pending PCR results for patients that are suspected to have COVID-19.
3. Hypoxemia on room air (SPO2\<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen).
4. Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
5. Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring is feasible.
Exclusion Criteria
2. Decreased level of consciousness (Glasgow Coma Scale score \<10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)
3. 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.
4. Body mass index \> 40 kg/m2
5. Pregnancy - third trimester.
6. Patient/substitute decision maker or caring physician's refusal to enroll in the study.
7. Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)
8. Intubation is not within patient's goals of care
9. Patient received awake proning session for \> 1 day prior to randomization
10. Previous intubation within the same hospital admission
18 Years
ALL
No
Sponsors
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King Abdullah International Medical Research Center
OTHER
McMaster University
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Waleed Al-Hazzani
Principal Investigator
Principal Investigators
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Waleed Alhazzani
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton
Yaseen Arabi
Role: PRINCIPAL_INVESTIGATOR
King Saud Bin Abdulaziz University for Health Sciences
Zainab Alduhailib
Role: PRINCIPAL_INVESTIGATOR
King Faisal Specialist Hospital and Research Center, Jeddah
Locations
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University of Texas Health Sciences Centre
Dallas, Texas, United States
Univeristy of Calgary
Calgary, Alberta, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, 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
Countries
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References
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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.
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.
Other Identifiers
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2154
Identifier Type: -
Identifier Source: org_study_id