Official Title
Evaluation of Prone Position in Conscious Patients on Nasal High-flow Oxygen Therapy for COVID-19 Disease Induced Acute Respiratory Distress Syndrome
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 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.

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 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.

Completed
Acute Respiratory Distress Syndrome
COVID-19

Other: Prone decubitus

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.

Eligibility Criteria

Inclusion Criteria:

- 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 Criteria:

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

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

Intensive Care Unit, Hospital,
Blois, France

Medical Intensive Care Unit, University Hospital, Brest
Brest, France

Medical Intensive Care Unit, Hospital, Béthune
Béthune, 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

Medical Intensive Care Unit, University Hospital, Grenoble
Grenoble, France

Intensive Care Unit, Hospital, La Roche-sur-Yon
La Roche-sur-Yon, France

Intensive Care Unit, Hospital, Le Mans
Le Mans, France

Intensive Care Unit, University Hospital, Lille
Lille, France

Medical Intensive Care Unit, University Hospital, Nantes
Nantes, France

Medical Intensive Care Unit, University Hospital, Nice
NIce, France

Medical Intensive Care Unit, Hospital, Orléans
Orléans, France

Medical Intensive Care Unit, Tenon-APHP
Paris, France

Medical Intensive Care Unit, University Hospital, Poitiers
Poitiers, France

Medical Intensive Care Unit, University Hospital, Tours
Tours, France

Surgical Intensive Care Unit, University Hospital, Tours
Tours, France

Intensive Care Unit, Hospital, Valence
Valence, France

Medical Intensive Care Unit, University Hospital, Nancy
Vandœuvre-lès-Nancy, France

Intensive Care Unit, Hospital, Vannes
Vannes, France

Yonatan PEREZ, MD, Study Director
No affiliation

University Hospital, Tours
NCT Number
Keywords
Acute Respiratory Distress Syndrome
Covid-19
SARS-CoV-2
Nasal High-Flow
Prone position
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome