MedDataX Logo

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

NCT ID: NCT04358939

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Distress Syndrome COVID-19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prone decubitus group

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

Group Type EXPERIMENTAL

Prone decubitus

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yonatan PEREZ, MD

Role: STUDY_DIRECTOR

No affiliation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Intensive Care Unit, University Hospital, Aix

Aix-en-Provence, , France

Site Status

Medical Intensive Care Unit, University Hospital, Amiens

Amiens, , France

Site Status

Intensive Care Unit, Hospital, Argenteuil

Argenteuil, , France

Site Status

Medical Intensive Care Unit, Hospital, Béthune

Béthune, , France

Site Status

Intensive Care Unit, Hospital,

Blois, , France

Site Status

Medical Intensive Care Unit, University Hospital, Brest

Brest, , France

Site Status

Medical Intensive Care Unit, University Hospital, Caen

Caen, , France

Site Status

Intensive Care Unit, Louis Mourier-APHP

Colombes, , France

Site Status

Intensive Care Unit, Hospital, Dax

Dax, , France

Site Status

Medical Intensive Care Unit, University Hospital, Dijon

Dijon, , France

Site Status

Medical Intensive Care Unit, University Hospital, Grenoble

Grenoble, , France

Site Status

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

La Roche-sur-Yon, , France

Site Status

Intensive Care Unit, Hospital, Le Mans

Le Mans, , France

Site Status

Intensive Care Unit, University Hospital, Lille

Lille, , France

Site Status

Medical Intensive Care Unit, University Hospital, Nantes

Nantes, , France

Site Status

Medical Intensive Care Unit, University Hospital, Nice

Nice, , France

Site Status

Medical Intensive Care Unit, Hospital, Orléans

Orléans, , France

Site Status

Medical Intensive Care Unit, Tenon-APHP

Paris, , France

Site Status

Medical Intensive Care Unit, University Hospital, Poitiers

Poitiers, , France

Site Status

Medical Intensive Care Unit, University Hospital, Tours

Tours, , France

Site Status

Surgical Intensive Care Unit, University Hospital, Tours

Tours, , France

Site Status

Intensive Care Unit, Hospital, Valence

Valence, , France

Site Status

Medical Intensive Care Unit, University Hospital, Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Intensive Care Unit, Hospital, Vannes

Vannes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 34425070 (View on PubMed)

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.

Reference Type RESULT
PMID: 34861160 (View on PubMed)

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.

Reference Type RESULT
PMID: 33177145 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A01121-38

Identifier Type: OTHER

Identifier Source: secondary_id

DR200125

Identifier Type: OTHER

Identifier Source: secondary_id

HIGH-PRONE-COVID-19

Identifier Type: -

Identifier Source: org_study_id