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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
268
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.
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
...and 9 more locations
Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups.
To show that PP in spontaneously ventilation patients could reduce the risk of acquiring the following event (composite endpoint): * Endotracheal intubation * Or non-invasive ventilation (NIV) with two pressure levels * And/or death
Time frame: Day 28
Duration in days for the change of 2 points on the WHO ordinal scale
Show that the use of prone position improves the WHO ordinal scale score by 2 points faster (after randomization)
Time frame: Day 28
Rate (%) of intubation and invasive ventilation in the 2 randomization groups.
Show that prone position with spontaneous ventilation reduces the need for endotracheal intubation and invasive mechanical ventilation
Time frame: Day 28
Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups
Show that prone position with spontaneous ventilation reduces the use of non-invasive ventilation at two pressure levels
Time frame: Day 28
Duration of oxygen therapy in the 2 randomization groups.
Show that prone position in spontaneous ventilation reduces the time under oxygen therapy.
Time frame: Day 28
Duration of hospitalization in the 2 randomization groups.
Show that prone position reduces the length of hospitalization.
Time frame: Day 28
Hospital mortality and mortality at D28 in the 2 randomization groups
Compare the hospital mortality of the 2 groups
Time frame: Day 28
Rate (%) of need for transfer to intensive care unit
Compare the incidence of the need for resuscitation transfer between the two groups.
Time frame: Day 28
Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days.
Compare the impact of the use of non-invasive ventilation and intubation on the entire hospital stay when the hospital stay is longer than 28 days between the two groups.
Time frame: 1 year
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