COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss

Hôpital de Verdun13 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronavirus Infection COVID Severe Acute Respiratory Syndrome Respiratory Failure Respiratory Insufficiency

Interventions

Awake Prone PositioningPROCEDURE

Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h

Standard carePROCEDURE

Patients will not receive any special instructions with regards to proning.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Hôtel-Dieu de Gaspé

Gaspé, Quebec, Canada

Hôpital de la Cité-de-la-Santé

Laval, Quebec, Canada

Montreal General Hospital, McGill University Healthcare Center

Montreal, Quebec, Canada

Royal Victoria Hospital, McGill University Healthcare Center

Montreal, Quebec, Canada

Hôpital de Verdun

Montreal, Quebec, Canada

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

Intubation rate

Time frame: Up to 28 days after randomization

Mortality

Time frame: Up to 28 days after randomization

Days spent on mechanical ventilation

Time frame: Until discharge, up to 24 weeks after randomization

Days spent in the ICU

Time frame: Until discharge, up to 24 weeks after randomization

Hospital stay (in days)

Time frame: From admission to discharge, up to 24 weeks after randomization