Status:
COMPLETED
Prone Position in Patients on High-flow Nasal Oxygen Therapy for COVID-19 (HIGH-PRONE-COVID-19)
Lead Sponsor:
University Hospital, Tours
Conditions:
Acute Respiratory Distress Syndrome
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Acute Respiratory Distress Syndrome (ARDS) induces high mortality, particularly in the context of COVID-19 disease. Preliminary data from patients with ARDS related to COVID-19 disease appear to show ...
Detailed Description
Acute Respiratory Distress Syndrome (ARDS) induces high mortality, particularly in the context of COVID-19 disease. In patients with ARDS who are mechanically ventilated invasively through a tracheal ...
Eligibility Criteria
Inclusion
- Adult patient
- with COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very highly suspected.
- Patient treated with nasal high-flow
- Mild, moderate or severe ARDS: bilateral radiological opacities not fully explained by effusions, atelectasis or nodules; acute hypoxemia with worsening within the previous 7 days, not fully explained by left ventricular failure; PaO2/FiO2 ratio \< 300 mmHg (or equivalent SpO2/FiO2).
- Covered by or having the rights to French social security
- Informed Consent
Exclusion
- Pregnant or breastfeeding woman
- Indication for immediate tracheal intubation
- Progressive significant acute circulatory insufficiency
- Impaired alertness, confusion, restlessness
- Body mass index \> 40 kg/m2
- Thoracic trauma or other contraindication to prone position
- Pneumothorax with single anterior thoracic drain and persistent bubbling
- Vulnerable person: safeguard of justice, guardianship or authorship known at inclusion
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2021
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT04358939
Start Date
April 27 2020
End Date
February 21 2021
Last Update
December 22 2025
Active Locations (24)
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1
Intensive Care Unit, University Hospital, Aix
Aix-en-Provence, France, 13616
2
Medical Intensive Care Unit, University Hospital, Amiens
Amiens, France, 80054
3
Intensive Care Unit, Hospital, Argenteuil
Argenteuil, France, 95100
4
Medical Intensive Care Unit, Hospital, Béthune
Béthune, France, 62408