Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
Completed · Not applicable
Conditions studied: Corona Virus Infection, Covid19, COVID-19
In brief
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.
Key facts
- Study ID
- NCT04350723
- Run by
- St. Joseph's Healthcare Hamilton
- People needed
- 400
- Starts
- 2020-06-10
- Expected to finish
- 2021-07-17
- Last updated by the study team
- 2021-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults ≥ 18 years of age.
- 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.
- Hypoxemia on room air (SPO2<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen).
- Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
- Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring is feasible.
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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