Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 5
- Primary Endpoint
- Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Awake prone positioning
Prone positioning of patients on nasal high-flow oxygen therapy
Intervention: Awake Prone Positioning (Procedure)
Standard care
Standard decubitus positioning of patients on nasal high-flow oxygen therapy
Intervention: Standard care (Procedure)
Outcomes
Primary Outcomes
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
Time Frame: Up to 28 days after randomization
Secondary Outcomes
- Mortality(Up to 28 days after randomization)
- Days spent on mechanical ventilation(Until discharge, up to 24 weeks after randomization)
- Hospital stay (in days)(From admission to discharge, up to 24 weeks after randomization)
- Days spent in the ICU(Until discharge, up to 24 weeks after randomization)
- Intubation rate(Up to 28 days after randomization)
Investigators
Ivan Pavlov
Emergency physician
Hôpital de Verdun