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 serious is acute respiratory distress syndrome (ARDS). The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation in mild forms to invasive mechanical ventilation in the most severe forms. Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al showed that PP and high flow oxygenation reduced the intubation in patients with moderate to severe ARDS. The investigators hypothesize that the use of PP in spontaneously ventilation patients under oxygen standard could decrease incidence of intubation or non-invasive ventilation or death compared to conventional positioning management in medical departments.
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 repeated prone sessions.
The control group will have conventional positioning: semi-seated in bed or seated in a
chair. The prone position is not allowed during the day (it is allowed at night if it is the
natural sleeping position).
The intervention group will have:
- Two sessions minimum of prone position over the day. With a total objective of at least
2h30 of cumulated duration over the day. The objective is to spend as much time as
possible in prone position if the patient tolerates it well.
- The maximum of prone position at night. Patients must be able to take position by
themselves or with minimal assistance. The rails will be positioned in order to prevent
falling out of bed. The patient will be free to choose his preferred prone position as
long as the back is not compressed
Other: prone position
Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
Inclusion Criteria:
- 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 Criteria:
- 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.
CH de Blois
Blois, France
CH de DAX
Dax, France
CHD de VENDEE
La Roche sur Yon, France
CH de LA ROCHELLE
La Rochelle, France
CH Le Mans
Le Mans, France
CH Mont de MArsan
Mont-de-Marsan, France
CHR d'Orléans - Service Pneumologie
Orléans, France
CHR d'Orleans - Service Maladies Infectieuses
Orléans, France
HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition
Paris, France
Hopital Européen Georges Pompidou
Paris, France
Hopital Lariboisiere - Medecine Interne
Paris, France
Hopital Lariboisiere
Paris, France
CH de PERPIGNAN - Service Maladies infectieuses
Perpignan, France
Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau
Quimper, France
CHRU de Tours - Service Médecine interne et immunologie Clinique
Tours, France
CHRU de Tours - Service Pneumologie
Tours, France
CHRU DE TOURS - Service Médecine interne et maladies infectieuses
Tours, France
CH Bretagne Atlantique
Vannes, France
centre Hospitalier Princesse Grace
Monaco, Monaco
Mai-Anh NAY, Dr, Study Chair
CHR Orléans