Coronavirus Infection, COVID, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome, ARDS, Lung Diseases
Conditions
Keywords
SARS-CoV-2, SARS-CoV-2 infection, COVID-19, HFNC, HFNO, Proning, Prone position, High-flow nasal cannula, High-flow nasal oxygenation, Acute Respiratory Distress Syndrome
Brief summary
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
Interventions
Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h
Patients will not receive any special instructions with regards to proning.
Sponsors
Study design
Eligibility
Inclusion criteria
* COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending; * Lung infiltrates documented on chest X-ray or chest CT-scan; * Significant respiratory distress that requires treatment with HFNO.
Exclusion criteria
* Unable to consent; * Unable to prone; * Indication for immediate endotracheal intubation and mechanical ventilation; * Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.); * Comfort care or imminent expectation of death.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death | Up to 28 days after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Intubation rate | Up to 28 days after randomization |
| Mortality | Up to 28 days after randomization |
| Days spent on mechanical ventilation | Until discharge, up to 24 weeks after randomization |
| Days spent in the ICU | Until discharge, up to 24 weeks after randomization |
| Hospital stay (in days) | From admission to discharge, up to 24 weeks after randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time in prone position | Up to 28 days post randomization | Total time spent in prone position, as recorded by nursing or respiratory therapists |
| Oxygenation (SpO2/FiO2 ratio) | Until HFNC weaning, or up to 14 days after randomization, whichever is first | Daily evolution of oxygenation |
Countries
Canada