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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04395144
Acronym
COVAYDE
Enrollment
13
Registered
2020-05-20
Start date
2020-05-15
Completion date
2021-03-15
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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

PROCEDUREStandard care

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

Sponsors

Hôpital de Verdun
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or deathUp to 28 days after randomization

Secondary

MeasureTime frame
Intubation rateUp to 28 days after randomization
MortalityUp to 28 days after randomization
Days spent on mechanical ventilationUntil discharge, up to 24 weeks after randomization
Days spent in the ICUUntil discharge, up to 24 weeks after randomization
Hospital stay (in days)From admission to discharge, up to 24 weeks after randomization

Other

MeasureTime frameDescription
Time in prone positionUp to 28 days post randomizationTotal time spent in prone position, as recorded by nursing or respiratory therapists
Oxygenation (SpO2/FiO2 ratio)Until HFNC weaning, or up to 14 days after randomization, whichever is firstDaily evolution of oxygenation

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026