Clinical trial NCT04395144: COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss
Official title: Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hôpital de Verdun
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
timeFrame: Up to 28 days after randomization
Secondary outcomes:
measure: Intubation rate
timeFrame: Up to 28 days after randomization
measure: Mortality
timeFrame: Up to 28 days after randomization
measure: Days spent on mechanical ventilation
timeFrame: Until discharge, up to 24 weeks after randomization
measure: Days spent in the ICU
timeFrame: Until discharge, up to 24 weeks after randomization
measure: Hospital stay (in days)
timeFrame: From admission to discharge, up to 24 weeks after randomization
Other outcomes:
measure: Time in prone position
timeFrame: Up to 28 days post randomization
measure: Oxygenation (SpO2/FiO2 ratio)
timeFrame: Until HFNC weaning, or up to 14 days after randomization, whichever is first
Locations:
city: Gaspé
country: Canada
facility: Hôtel-Dieu de Gaspé
state: Quebec
city: Laval
country: Canada
facility: Hôpital de la Cité-de-la-Santé
state: Quebec
city: Montréal
country: Canada
facility: Montreal General Hospital, McGill University Healthcare Center
state: Quebec
city: Montréal
country: Canada
facility: Royal Victoria Hospital, McGill University Healthcare Center
state: Quebec
city: Montréal
country: Canada
facility: Hôpital de Verdun
state: Quebec
Study officials:
affiliation: Hôpital de Verdun
name: Ivan Pavlov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.