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

Respiratory Failure Clinical Trial

— COVAYDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395144
• Other study ID #: 2021-01
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2021
• Source: Hôpital de Verdun
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• ARDS
• Coronavirus Infection
• Coronavirus Infections
• COVID
• Lung Diseases
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

Procedure:
• Awake Prone Positioning
Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h
• Standard care
Patients will not receive any special instructions with regards to proning.

Locations

Country	Name	City	State
Canada	Hôtel-Dieu de Gaspé	Gaspé	Quebec
Canada	Hôpital de la Cité-de-la-Santé	Laval	Quebec
Canada	Hôpital de Verdun	Montréal	Quebec
Canada	Montreal General Hospital, McGill University Healthcare Center	Montréal	Quebec
Canada	Royal Victoria Hospital, McGill University Healthcare Center	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital de Verdun

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time in prone position	Total time spent in prone position, as recorded by nursing or respiratory therapists	Up to 28 days post randomization
Other	Oxygenation (SpO2/FiO2 ratio)	Daily evolution of oxygenation	Until HFNC weaning, or up to 14 days after randomization, whichever is first
Primary	Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death		Up to 28 days after randomization
Secondary	Intubation rate		Up to 28 days after randomization
Secondary	Mortality		Up to 28 days after randomization
Secondary	Days spent on mechanical ventilation		Until discharge, up to 24 weeks after randomization
Secondary	Days spent in the ICU		Until discharge, up to 24 weeks after randomization
Secondary	Hospital stay (in days)		From admission to discharge, up to 24 weeks after randomization