Official Title
Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
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.

Completed
Coronavirus Infection
COVID
Severe Acute Respiratory Syndrome
Respiratory Failure
Respiratory Insufficiency
Respiratory Distress Syndrome
ARDS
Lung Diseases

Procedure: Awake Prone Positioning

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

Procedure: Standard care

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Canada
Locations

Hôtel-Dieu de Gaspé
Gaspé, Quebec, Canada

Hôpital de la Cité-de-la-Santé
Laval, Quebec, Canada

Montreal General Hospital, McGill University Healthcare Center
Montréal, Quebec, Canada

Royal Victoria Hospital, McGill University Healthcare Center
Montréal, Quebec, Canada

Hôpital de Verdun
Montréal, Quebec, Canada

Ivan Pavlov, MD, Principal Investigator
Hôpital de Verdun

Hôpital de Verdun
NCT Number
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
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Lung Diseases
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Syndrome