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 significant effectiveness of prone positioning in intubated patients in terms of oxygenation as well as nasal high flow therapy before intubation. It should be noted that in Jiangsu province, secondarily affected, nasal high flow combined with the prone position was successfully integrated into care protocols. The investigators hypothesize that the combined application of nasal high flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for tracheal intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources. Investigators hypothesize that the combined application of nasal high-flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.
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 tube and with a PaO2/FiO2 ratio (arterial oxygen partial pressure to inspired oxygen fraction ratio) of less than 150 mmHg, prone positioning significantly reduced mortality. Furthermore, nasal high flow, a non-invasive respiratory support and oxygenation technique, reduced the need for tracheal intubation and reduced mortality among the most severe patients (PaO2/FiO2 ratio less than 200 mmHg) suffering from acute hypoxemic respiratory failure. Prone positioning of ARDS patients treated with nasal high-flow was evaluated in 20 patients with predominantly viral pneumonia. The prone positioning was found to be feasible and associated with an increased PaO2/FiO2 ratio. Preliminary data from patients with ARDS related to COVID-19 disease appear to show a significant effect of prone positioning in intubated patients in terms of oxygenation improvement as well as nasal high-high flow appears effective in non-intubated patients. For instance, nearly half intensive care unit patients described in the princeps cohort in Wuhan City, Hubei Province, China, had received nasal high-flow. It should be noted that in Jiangsu province, secondarily affected, nasal high-flow combined with prone positioning was successfully integrated into care protocols. Investigators hypothesize that the combined application of nasal high-flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
405
According to the tolerance, the objective is to spend as much time as possible, up to 16 hours and beyond in prone position every 24 hours. At least two sessions of at least 30 minutes each must be performed daily.
Intensive Care Unit, University Hospital, Aix
Aix-en-Provence, France
Medical Intensive Care Unit, University Hospital, Amiens
Amiens, France
Intensive Care Unit, Hospital, Argenteuil
Argenteuil, France
Medical Intensive Care Unit, Hospital, Béthune
Béthune, France
Intensive Care Unit, Hospital,
Blois, France
Medical Intensive Care Unit, University Hospital, Brest
Brest, France
Medical Intensive Care Unit, University Hospital, Caen
Caen, France
Intensive Care Unit, Louis Mourier-APHP
Colombes, France
Intensive Care Unit, Hospital, Dax
Dax, France
Medical Intensive Care Unit, University Hospital, Dijon
Dijon, France
...and 14 more locations
Therapeutic failure within 14 days of randomization
Therapeutic failure is defined by death or intubation or use of non-invasive ventilation at two pressure levels.
Time frame: From randomization to day 14
Therapeutic failure within 28 days of randomization
Therapeutic failure is defined by death or intubation or use of non-invasive ventilation at two pressure levels.
Time frame: From randomization to day 28
Timeframe of intubation or death
Time frame: From randomization to day 28
Timeframe of therapeutic escalation (in case of non-invasive ventilation at two pressure levels)
Time frame: From randomization to day 28
Evolution of oxygenation (PaO2/FiO2 ratio or SpO2/FiO2 surrogate) over the 14 days following randomization
Time frame: From randomization to day 14
Evolution of the SpO2/FiO2 ratio during the first prone session
Time frame: From randomization to day 1
Evolution of the ROX index during the first prone session
ROX index is the ratio of pulse oximetry (SpO2)/fraction of inspired oxygen (FiO2) to respiratory rate.
Time frame: From randomization to day 1
Evolution of the World Health Organization disease severity score of COVID
Score reaches from 1 to 7, 7 indicates worse outcome
Time frame: From randomization to day 28
Patient comfort before, during and after the first prone position session
Comfort evaluted by the patient through a visual analogical scale
Time frame: From randomization to day 1
Occurrence of skin lesions on the anterior surface of the body
Time frame: From randomization to day 28
Displacement of invasive devices during reversals
Invasive devices include : central and peripheric vascular catheters, tracheal tube, urinary catheter, chest tubes.
Time frame: From randomization to day 28
Days of nasal High-Flow therapy use in the general population, in non-intubated patients and in intubated patients
Time frame: From randomization to day 28
Days spent in the intensive care unit and in the hospital
Time frame: From randomization to day 28
Mortality in the intensive care unit and in the hospital
Time frame: From randomization to day 28
Ventilator-free-days within 28 days of randomization
Time frame: From randomization to day 28
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