Clinical trial NCT04358939: Prone Position in Patients on High-flow Nasal Oxygen Therapy for COVID-19 (HIGH-PRONE-COVID-19)
Official title: Evaluation of Prone Position in Conscious Patients on Nasal High-flow Oxygen Therapy for COVID-19 Disease Induced Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
COVID-19
Keywords: Acute Respiratory Distress Syndrome
COVID-19
SARS-CoV-2
Nasal High-Flow
Prone position
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Therapeutic failure within 14 days of randomization
timeFrame: From randomization to day 14
Secondary outcomes:
measure: Therapeutic failure within 28 days of randomization
timeFrame: From randomization to day 28
measure: Timeframe of intubation or death
timeFrame: From randomization to day 28
measure: Timeframe of therapeutic escalation (in case of non-invasive ventilation at two pressure levels)
timeFrame: From randomization to day 28
measure: Evolution of oxygenation (PaO2/FiO2 ratio or SpO2/FiO2 surrogate) over the 14 days following randomization
timeFrame: From randomization to day 14
measure: Evolution of the SpO2/FiO2 ratio during the first prone session
timeFrame: From randomization to day 1
measure: Evolution of the ROX index during the first prone session
timeFrame: From randomization to day 1
measure: Evolution of the World Health Organization disease severity score of COVID
timeFrame: From randomization to day 28
measure: Patient comfort before, during and after the first prone position session
timeFrame: From randomization to day 1
measure: Occurrence of skin lesions on the anterior surface of the body
timeFrame: From randomization to day 28
measure: Displacement of invasive devices during reversals
timeFrame: From randomization to day 28
measure: Days of nasal High-Flow therapy use in the general population, in non-intubated patients and in intubated patients
timeFrame: From randomization to day 28
measure: Days spent in the intensive care unit and in the hospital
timeFrame: From randomization to day 28
measure: Mortality in the intensive care unit and in the hospital
timeFrame: From randomization to day 28
measure: Ventilator-free-days within 28 days of randomization
timeFrame: From randomization to day 28
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Intensive Care Unit, University Hospital, Aix
city: Amiens
country: France
facility: Medical Intensive Care Unit, University Hospital, Amiens
city: Argenteuil
country: France
facility: Intensive Care Unit, Hospital, Argenteuil
city: Blois
country: France
facility: Intensive Care Unit, Hospital,
city: Brest
country: France
facility: Medical Intensive Care Unit, University Hospital, Brest
city: Béthune
country: France
facility: Medical Intensive Care Unit, Hospital, Béthune
city: Caen
country: France
facility: Medical Intensive Care Unit, University Hospital, Caen
city: Colombes
country: France
facility: Intensive Care Unit, Louis Mourier-APHP
city: Dax
country: France
facility: Intensive Care Unit, Hospital, Dax
city: Dijon
country: France
facility: Medical Intensive Care Unit, University Hospital, Dijon
city: Grenoble
country: France
facility: Medical Intensive Care Unit, University Hospital, Grenoble
city: La Roche-sur-Yon
country: France
facility: Intensive Care Unit, Hospital, La Roche-sur-Yon
city: Le Mans
country: France
facility: Intensive Care Unit, Hospital, Le Mans
city: Lille
country: France
facility: Intensive Care Unit, University Hospital, Lille
city: Nantes
country: France
facility: Medical Intensive Care Unit, University Hospital, Nantes
city: NIce
country: France
facility: Medical Intensive Care Unit, University Hospital, Nice
city: Orléans
country: France
facility: Medical Intensive Care Unit, Hospital, Orléans
city: Paris
country: France
facility: Medical Intensive Care Unit, Tenon-APHP
city: Poitiers
country: France
facility: Medical Intensive Care Unit, University Hospital, Poitiers
city: Tours
country: France
facility: Medical Intensive Care Unit, University Hospital, Tours
city: Tours
country: France
facility: Surgical Intensive Care Unit, University Hospital, Tours
city: Valence
country: France
facility: Intensive Care Unit, Hospital, Valence
city: Vandœuvre-lès-Nancy
country: France
facility: Medical Intensive Care Unit, University Hospital, Nancy
city: Vannes
country: France
facility: Intensive Care Unit, Hospital, Vannes
Study officials:
affiliation: No affiliation
name: Yonatan PEREZ, MD
role: STUDY_DIRECTOR
References:
citation: Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
citation: Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.