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

H

Hôpital de Verdun

Status

Completed

Conditions

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

Treatments

Procedure: Standard care
Procedure: Awake Prone Positioning

Study type

Interventional

Funder types

Other

Identifiers

NCT04395144
2021-01

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 2 patient groups

Awake prone positioning
Experimental group
Description:
Prone positioning of patients on nasal high-flow oxygen therapy
Treatment:
Procedure: Awake Prone Positioning
Standard care
Active Comparator group
Description:
Standard decubitus positioning of patients on nasal high-flow oxygen therapy
Treatment:
Procedure: Standard care

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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