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

NCT04395144 | Completed DMC

• 1 other identifier: 2021-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death

  Up to 28 days after randomization

Secondary Outcomes (5)

• Intubation rate

  Up to 28 days after randomization

• Mortality

  Up to 28 days after randomization

• Days spent on mechanical ventilation

  Until discharge, up to 24 weeks after randomization

• Days spent in the ICU

  Until discharge, up to 24 weeks after randomization

• Hospital stay (in days)

  From admission to discharge, up to 24 weeks after randomization

Other Outcomes (2)

• Time in prone position

  Up to 28 days post randomization

• Oxygenation (SpO2/FiO2 ratio)

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

Study Arms (2)

Awake prone positioning

EXPERIMENTAL

Prone positioning of patients on nasal high-flow oxygen therapy

Procedure: Awake Prone Positioning

Standard care

ACTIVE COMPARATOR

Standard decubitus positioning of patients on nasal high-flow oxygen therapy

Procedure: Standard care

Interventions

Awake Prone Positioning PROCEDURE

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

Awake prone positioning

Standard care PROCEDURE

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

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital de Verdun: lead

Study Sites (5)

Hôtel-Dieu de Gaspé

Gaspé, Quebec, G4X 2W2, Canada

Location

Hôpital de la Cité-de-la-Santé

Laval, Quebec, H7M 3L9, Canada

Location

Montreal General Hospital, McGill University Healthcare Center

Montreal, Quebec, H3G 1A4, Canada

Location

Royal Victoria Hospital, McGill University Healthcare Center

Montreal, Quebec, H4A 3J1, Canada

Location

Hôpital de Verdun

Montreal, Quebec, H4G2A2, Canada

Location

Related Publications (2)

• Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.

  PMID: 34425070 DERIVED

• Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.

  PMID: 33177145 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Severe Acute Respiratory Syndrome; Respiratory Insufficiency; Respiratory Distress Syndrome; Lung Diseases; COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ivan Pavlov, MD

  Hôpital de Verdun

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency physician

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: May 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)