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OpenTrials
Completed

NCT Number: NCT04395144

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

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.

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Key information

Conditions

Coronavirus Infection ARDS COVID COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôtel-Dieu de Gaspé, Gaspé, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Awake Prone Positioning

Procedure

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

Standard care

Procedure

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

Primary outcomes

  1. 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

  1. Intubation rate

    Time frame: Up to 28 days after randomization

  2. Mortality

    Time frame: Up to 28 days after randomization

  3. Days spent on mechanical ventilation

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

  4. Days spent in the ICU

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

  5. Hospital stay (in days)

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

Other outcomes

  1. Time in prone position

    Time frame: Up to 28 days post randomization

    Total time spent in prone position, as recorded by nursing or respiratory therapists

  2. Oxygenation (SpO2/FiO2 ratio)

    Time frame: Until HFNC weaning, or up to 14 days after randomization, whichever is first

    Daily evolution of oxygenation

Sponsors and collaborators

Lead sponsor

Hôpital de Verdun

Other

Registry information

Official study title

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

Acronym: COVAYDE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 20, 2020
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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