Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
- Conditions
- Corona Virus InfectionCovid19COVID-19
- Registration Number
- NCT04350723
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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.
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Immediate need for intubation as determined by the treating team.
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Decreased level of consciousness (Glasgow Coma Scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)
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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.
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Body mass index > 40 kg/m2
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Pregnancy - third trimester.
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Patient/substitute decision maker or caring physician's refusal to enroll in the study.
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Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)
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Intubation is not within patient's goals of care
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Patient received awake proning session for > 1 day prior to randomization
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Previous intubation within the same hospital admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Endotracheal intubation within 30 days of randomization Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
- Secondary Outcome Measures
Name Time Method Mortality 60 days Death
Days alive and outside of hospital 60 days Number of days alive and outside of hospital
Complications from proning, 30 days Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.
Invasive mechanical ventilation free days censored at 30 Days Number of days not receiving mechanical ventilation
Days alive and outside ICU 60 Days Number of days alive and outside the ICU
Non-invasive ventilation free days censored 30 days Number of days not receiving non-invasive mechanical ventilation
Trial Locations
- Locations (17)
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
Scroll for more (7 remaining)University of Texas Health Sciences Centre🇺🇸Dallas, Texas, United States