Status:
COMPLETED
Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
COVID19
Oxygen Therapy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most seriou...
Detailed Description
This is a multicenter randomized controlled study. 400 patients with COVID-19 documentation and undergoing oxygen therapy will be randomly assigned, with a 1:1 ratio, to conventional positioning or re...
Eligibility Criteria
Inclusion
- Patients aged from 18 to 85 years old
- With COVID-19 documentation
- Undergoing oxygen therapy (nasal cannula, medium or high concentration mask or high flow nasal oxygen therapy)
- Able to move to PP by him/herself or with minimal assistance
- Written consent
- Hospitalized in COVID medical department for less than 72 hours
Exclusion
- Pregnant (positive pregnancy test during screening) or breastfeeding women
- Patient on long-term oxygen therapy or Continuous Positive Airway Pressure (CPAP) or Non-Invasive Ventilation (NIV) at home
- Chronic Obstructive Pulmonary Disease (COPD) Patient stage 3 or 4
- Patient with known chronic diffuse interstitial lung disease
- Patient with neuromuscular pathology
- Contraindication to the PP (recent thoracic trauma, pneumothorax, orthopaedic fracture preventing mobilization, ...)
- Deep vein thrombosis of the lower limbs or pulmonary embolism with effective anticoagulation for less than 48 hours
- Hemodynamic instability (MAP \< 65 mm Hg) persisting for more than 1 hour
- Respiratory rate greater than 40 cycles per minute
- Excessive use of accessory respiratory muscles (as judged by the clinician)
- Indication for curative NIV (acute pulmonary edema or acute hypercapnic respiratory failure)
- Intestinal Occlusive Syndrome
- Patient unable to protect upper airway
- Inability to understand French or to follow instructions for the prone position.
- Person under guardianship
- Protected Majors
- Not affiliated to French social security
- Decision not to forgo life sustaining therapy
- Patient discharged from an intensive care unit and has been treated by invasive or non-invasive mechanical ventilation at 2 pressure levels during the resuscitation stay.
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2022
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04363463
Start Date
August 28 2020
End Date
January 13 2022
Last Update
December 28 2022
Active Locations (19)
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1
CH de Blois
Blois, France, 41016
2
CH de DAX
Dax, France, 40100
3
CHD de VENDEE
La Roche-sur-Yon, France, 85925
4
CH de LA ROCHELLE
La Rochelle, France, 17019