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.
Procedure: Awake Proning
The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
Inclusion Criteria:
1. Adults ≥ 18 years of age.
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:
1. Immediate need for intubation as determined by the treating team.
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
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
Quebec, Canada
Al-Amir Hospital
Kuwait, Kuwait
Jaber Al Ahmed hospital
Kuwait, 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