NCT04350723
Completed
Not Applicable
Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Corona Virus Infection
- Sponsor
- St. Joseph's Healthcare Hamilton
- Enrollment
- 400
- Locations
- 17
- Primary Endpoint
- Endotracheal intubation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Waleed Al-Hazzani
Principal Investigator
St. Joseph's Healthcare Hamilton
Eligibility Criteria
Inclusion Criteria
- •Adults ≥ 18 years of age.
- •Suspected or confirmed COVID-
- •Defined as: a positive PCR for SARS CoV-2 or pending PCR results for patients that are suspected to have COVID-
- •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.
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
Outcomes
Primary Outcomes
Endotracheal intubation
Time Frame: within 30 days of randomization
Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
Secondary Outcomes
- Mortality(60 days)
- Days alive and outside of hospital(60 days)
- Complications from proning,(30 days)
- Invasive mechanical ventilation free days(censored at 30 Days)
- Days alive and outside ICU(60 Days)
- Non-invasive ventilation free days(censored 30 days)
Study Sites (17)
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