Prone Position in Patients on High-flow Nasal Oxygen Therapy for COVID-19 (HIGH-PRONE-COVID-19)

NCT04358939 | Completed

• 3 other identifiers: HIGH-PRONE-COVID-192020-A01121-38DR200125
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 24

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.

Conditions

COVID-19; Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; COVID-19; SARS-CoV-2; Nasal High-Flow; Prone position

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to day 14

Secondary Outcomes (14)

• Therapeutic failure within 28 days of randomization

  From randomization to day 28

• Timeframe of intubation or death

  From randomization to day 28

• Timeframe of therapeutic escalation (in case of non-invasive ventilation at two pressure levels)

  From randomization to day 28

• Evolution of oxygenation (PaO2/FiO2 ratio or SpO2/FiO2 surrogate) over the 14 days following randomization

  From randomization to day 14

• Evolution of the SpO2/FiO2 ratio during the first prone session

  From randomization to day 1

Study Arms (2)

Prone decubitus group

EXPERIMENTAL

Prone positioning of patients on nasal high-flow oxygen therapy with usual care

Other: Prone decubitus

Control group

NO INTERVENTION

Patients on nasal high-flow oxygen therapy with usual care and positioned in supine

Interventions

Prone decubitus OTHER

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.

Prone decubitus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (24)

Intensive Care Unit, University Hospital, Aix

Aix-en-Provence, 13616, France

Location

Medical Intensive Care Unit, University Hospital, Amiens

Amiens, 80054, France

Location

Intensive Care Unit, Hospital, Argenteuil

Argenteuil, 95100, France

Location

Medical Intensive Care Unit, Hospital, Béthune

Béthune, 62408, France

Location

Intensive Care Unit, Hospital,

Blois, 41016, France

Location

Medical Intensive Care Unit, University Hospital, Brest

Brest, 29609, France

Location

Medical Intensive Care Unit, University Hospital, Caen

Caen, 14033, France

Location

Intensive Care Unit, Louis Mourier-APHP

Colombes, 92700, France

Location

Intensive Care Unit, Hospital, Dax

Dax, 40107, France

Location

Medical Intensive Care Unit, University Hospital, Dijon

Dijon, 21033, France

Location

Medical Intensive Care Unit, University Hospital, Grenoble

Grenoble, France

Location

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

La Roche-sur-Yon, 85925, France

Location

Intensive Care Unit, Hospital, Le Mans

Le Mans, 72037, France

Location

Intensive Care Unit, University Hospital, Lille

Lille, 59037, France

Location

Medical Intensive Care Unit, University Hospital, Nantes

Nantes, 44093, France

Location

Medical Intensive Care Unit, University Hospital, Nice

Nice, 06202, France

Location

Medical Intensive Care Unit, Hospital, Orléans

Orléans, 45067, France

Location

Medical Intensive Care Unit, Tenon-APHP

Paris, 75020, France

Location

Medical Intensive Care Unit, University Hospital, Poitiers

Poitiers, 86021, France

Location

Medical Intensive Care Unit, University Hospital, Tours

Tours, 37044, France

Location

Surgical Intensive Care Unit, University Hospital, Tours

Tours, 37170, France

Location

Intensive Care Unit, Hospital, Valence

Valence, 26953, France

Location

Medical Intensive Care Unit, University Hospital, Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Intensive Care Unit, Hospital, Vannes

Vannes, 56017, France

Location

Related Publications (3)

• 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.

  PMID: 34425070 RESULT

• Ibarra-Estrada M, Li J, Laffey JG, Pavlov I, Roca O, Perez Y, McNicholas B, Vines D, Tavernier E, Ehrmann S. Prone positioning might reduce the need for intubation in people with severe COVID-19 - Authors' reply. Lancet Respir Med. 2021 Dec;9(12):e111. doi: 10.1016/S2213-2600(21)00449-5. No abstract available.

  PMID: 34861160 RESULT

• 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.

  PMID: 33177145 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Yonatan PEREZ, MD

  No affiliation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: April 27, 2020
• Primary Completion: February 21, 2021
• Study Completion: February 21, 2021
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available immediately following publication and ending in 5 years.
• Access Criteria: Contact with the corresponding author.

Locations

FR (24)