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

Not Applicable

Completed

• Conditions: Lung Diseases; Coronavirus Infection; Respiratory Failure; COVID; Respiratory Insufficiency; Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; ARDS
• Interventions: Procedure: Awake Prone Positioning; Procedure: Standard care

• Registration Number: NCT04395144
• Lead Sponsor: Hôpital de Verdun

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Status Verified: 2021-03
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Last Update Submitted: 2021-03-21
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Awake prone positioning	Awake Prone Positioning	Prone positioning of patients on nasal high-flow oxygen therapy
Standard care	Standard care	Standard decubitus positioning of patients on nasal high-flow oxygen therapy

Primary Outcome Measures

Name	Time	Method
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death	Up to 28 days after randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Hôpital de la Cité-de-la-Santé; 🇨🇦 Laval, Quebec, Canada

Hôpital de Verdun; 🇨🇦 Montréal, Quebec, Canada

Royal Victoria Hospital, McGill University Healthcare Center; 🇨🇦 Montréal, Quebec, Canada

Hôtel-Dieu de Gaspé; 🇨🇦 Gaspé, Quebec, Canada

Montreal General Hospital, McGill University Healthcare Center; 🇨🇦 Montréal, Quebec, Canada