Corona Virus Infection, Covid19, COVID-19
Conditions
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.
Interventions
PROCEDUREAwake Proning
The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
Sponsors
King Abdullah International Medical Research Center
McMaster University
Canadian Institutes of Health Research (CIHR)
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A multicenter, parallel-group randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endotracheal intubation | within 30 days of randomization | Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasive mechanical ventilation free days | censored at 30 Days | Number of days not receiving mechanical ventilation |
| Non-invasive ventilation free days | censored 30 days | Number of days not receiving non-invasive mechanical ventilation |
| 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. |
| Days alive and outside ICU | 60 Days | Number of days alive and outside the ICU |
Countries
Canada, Kuwait, Saudi Arabia, United States
Outcome results
None listed