NCT04358939

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

Completed NA Last updated 22 December 2025

What this trial tests

NA trial testing Prone decubitus in Acute Respiratory Distress Syndrome in 405 participants. Completed in 21 February 2021.

Timeline

27 April 2020

Primary endpoint
21 February 2021

21 February 2021

Quick facts

Lead sponsor	University Hospital, Tours
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	405
Start date	27 April 2020
Primary completion	21 February 2021
Estimated completion	21 February 2021
Sites	24 locations across France

Drugs / interventions tested

• Prone decubitus

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
• COVID-19 — all drugs for COVID-19 →

Sponsor

University Hospital, Tours

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial.
   Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, et al · · 2021 · cited 271× · PMID 34425070 · DOI 10.1016/s2213-2600(21)00356-8
2. Awake prone positioning for hypoxaemic respiratory failure: past, COVID-19 and perspectives.
   Touchon F, Trigui Y, Prud'homme E, Lefebvre L, et al · · 2021 · cited 40× · PMID 33952601 · DOI 10.1183/16000617.0022-2021
3. Prone position in COVID 19-associated acute respiratory failure.
   Kharat A, Simon M, Guérin C. · · 2022 · cited 24× · PMID 34750322 · DOI 10.1097/mcc.0000000000000900
4. Prone positioning in conscious patients on medical wards: A review of the evidence and its relevance to patients with COVID-19 infection.
   Chad T, Sampson C. · · 2020 · cited 16× · PMID 32503800 · DOI 10.7861/clinmed.2020-0179
5. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial.
   Tavernier E, McNicholas B, Pavlov I, Roca O, et al · · 2020 · cited 14× · PMID 33177145 · DOI 10.1136/bmjopen-2020-041520
6. Awake prone positioning for patients with COVID-19 pneumonia in intensive care unit: A systematic review and meta-analysis.
   Huang HB, Yao Y, Zhu YB, Du B. · · 2022 · cited 2× · PMID 36160173 · DOI 10.3389/fmed.2022.984446
7. What is the most adequate non-invasive oxygen support for acute hypoxaemic respiratory failure due to COVID-19?
   Frat JP, Thille AW, Arrivé F, Lujan M, et al · · 2021 · cited 1× · PMID 34157444 · DOI 10.1016/j.accpm.2021.100909
8. [Noninvasive ventilation and positional therapy in COVID-19 : Case report and literature review].
   Sellmann T, Maurer C, Thal SC. · · 2021 · cited 1× · PMID 33961076 · DOI 10.1007/s00101-021-00973-0