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Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)

Not Applicable
Completed
Conditions
Corona Virus Infection
Covid19
COVID-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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Endotracheal intubationwithin 30 days of randomization

Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.

Secondary Outcome Measures
NameTimeMethod
Mortality60 days

Death

Days alive and outside of hospital60 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 dayscensored at 30 Days

Number of days not receiving mechanical ventilation

Days alive and outside ICU60 Days

Number of days alive and outside the ICU

Non-invasive ventilation free dayscensored 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

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University of Texas Health Sciences Centre
🇺🇸Dallas, Texas, United States

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