Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy (PRONECAP)

April 28, 2026 updated by: University Hospital, Tours

Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19

Community acquired pneumonia, in particular when requiring oxygen therapy because of acute hypoxemic respiratory failure and meeting acute respiratory distress syndrome (ARDS) criteria frequently leads to tracheal intubation and poor outcome.

Among invasively mechanically ventilated patients with ARDS and presenting a PaO2/FiO2 ratio (arterial partial pressure of oxygen to inspired fraction of oxygen) of less than 150 mmHg, the prone position significantly reduces mortality and represents standard care (Guérin 2013). Among non-intubated COVID-19 patients, a subtype of viral community acquired pneumonia, a recent study showed that awake prone positioning reduces the composite outcome of intubation or death among patients requiring nasal high flow therapy. Furthermore, it favored weaning of nasal high flow therapy.

Prone position in patients with non-COVID ARDS treated with high nasal flow was evaluated in 20 patients with predominantly viral pneumonia (Ding 2020) and was associated with improved oxygenation.

Coordinating investigator hypothesize that prone positioning of patients suffering non-COVID community acquired pneumonia and undergoing nasal high flow therapy can significantly improve outcome by reducing the need for intubation and associated therapies such as sedation and muscle relaxation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1078

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • Intensive care, University Hospital, Amiens
        • Contact:
          • Clément BRAULT
        • Principal Investigator:
          • Clément BRAULT
      • Angers, France
        • Not yet recruiting
        • Intensive care, University Hospital, Angers
        • Contact:
          • Pierre ASFAR
        • Principal Investigator:
          • Pierre ASFAR
      • Argenteuil, France
        • Not yet recruiting
        • Intensive care, University Hospital, Argenteuil
        • Contact:
          • Gaëtan PLANTEFEVE
        • Principal Investigator:
          • Gaëtan PLANTEFEVE
      • Belfort, France
        • Not yet recruiting
        • Intensive care, University Hospital, Belfort
        • Contact:
          • Julio BADIE
        • Principal Investigator:
          • Julio BADIE
      • Besançon, France
        • Not yet recruiting
        • Intensive care, University Hospital, Besancon
        • Contact:
          • Thibault VIEILLE
        • Principal Investigator:
          • Thibault VIEILLE
      • Blois, France
        • Not yet recruiting
        • Intensive care, University Hospital, Blois
        • Principal Investigator:
          • Julien GROUILLE
        • Contact:
          • Julien GROUILLE
      • Bordeaux, France
        • Not yet recruiting
        • Intensive care, University Hospital, Bordeaux
        • Contact:
          • Alexandre BOYER
        • Principal Investigator:
          • Alexandre BOYER
      • Bourg-en-Bresse, France
        • Not yet recruiting
        • Intensive care, University Hospital, Bourg en Bresse
        • Contact:
          • Nicholas SEDILLOT
        • Principal Investigator:
          • Nicholas SEDILLOT
      • Bourges, France
        • Recruiting
        • Intensive care, University Hospital, Bourges
        • Principal Investigator:
          • Anna BOURREAU
        • Contact:
          • Anna BOURREAU
      • Brest, France
        • Not yet recruiting
        • Intensive care, University Hospital, Brest
        • Contact:
          • Gwénaël PRAT
        • Principal Investigator:
          • Gwénaël PRAT
      • Béthune, France
        • Not yet recruiting
        • Intensive care, University Hospital, Bethune
        • Contact:
          • Ghada SBOUI
        • Principal Investigator:
          • Ghada SBOUI
      • Colombes, France
        • Not yet recruiting
        • Intensive care, University Hospital, Colombes
        • Contact:
          • Damien ROUX
        • Principal Investigator:
          • Damien ROUX Damien
      • Dieppe, France
        • Not yet recruiting
        • Intensive care, University Hospital, Dieppe
        • Contact:
          • Pierre-Louis DECLERCQ
        • Principal Investigator:
          • Pierre-Louis DECLERCQ
      • Dijon, France
        • Recruiting
        • Intensive care, University Hospital, Dijon
        • Contact:
          • Jean-Pierre QUENOT
        • Principal Investigator:
          • Jean-Pierre QUENOT
      • Dreux, France
        • Not yet recruiting
        • Intensive care, University Hospital, Dreux
        • Contact:
          • Florent BAVOZET
        • Principal Investigator:
          • Florent BAVOZET
      • Garche, France
        • Not yet recruiting
        • Intensive care, University Hospital, Garches
        • Principal Investigator:
          • Djillali ANNANE
        • Contact:
          • Djillali ANNANE
      • Grenoble, France
        • Not yet recruiting
        • Intensive care, University Hospital, Grenoble
        • Contact:
          • Guilhem WATTECAMPS
        • Principal Investigator:
          • Guilhem WATTECAMPS
      • La Roche-sur-Yon, France
        • Recruiting
        • Intensive care, University Hospital, La Roche sur Yon
        • Contact:
          • Jean-Claude LACHERADE
        • Principal Investigator:
          • Jean-Claude LACHERADE
      • Le Mans, France
        • Recruiting
        • Intensive care, University Hospital, Le Mans
        • Principal Investigator:
          • Mickaël LANDAIS
        • Contact:
          • Mickael LANDAIS
      • Lens, France
        • Recruiting
        • Intensive care, University Hospital, Lens
        • Contact:
          • Camille PROUTEAU
        • Principal Investigator:
          • Camille PROUTEAU
      • Lille, France
        • Not yet recruiting
        • Intensive care, University Hospital, Lille
        • Contact:
          • Saadalla NSEIR
        • Principal Investigator:
          • Saadalla NSEIR
      • Lorient, France
        • Not yet recruiting
        • Intensive care, University Hospital, Lorient
        • Contact:
          • Guillaume GRILLET
        • Principal Investigator:
          • Guillaume GRILLET
      • Lyon, France
        • Not yet recruiting
        • Intensive care, University Hospital, Lyon
        • Principal Investigator:
          • Laurent ARGAUD
        • Contact:
          • Laurent ARGAUD
      • Morlaix, France
        • Recruiting
        • Intensive care, University Hospital, Morlaix
        • Principal Investigator:
          • Pierre-Yves EGRETEAU
        • Contact:
          • Pierre-Yves EGRETEAU
      • Nantes, France
        • Recruiting
        • Intensive care, University Hospital, Nantes
        • Principal Investigator:
          • Jean REIGNIER
        • Contact:
          • Jean REIGNIER
      • Nice, France
        • Not yet recruiting
        • Intensive care, University Hospital, Nice
        • Contact:
          • Robert ALEXANDRE
        • Principal Investigator:
          • Robert ALEXANDRE
      • Orléans, France
        • Not yet recruiting
        • Intensive care, University Hospital, Orléans
        • Contact:
          • François BARBIER
        • Principal Investigator:
          • François BARBIER
      • Paris, France
        • Not yet recruiting
        • Intensive care, University Hospital, Cochin
        • Principal Investigator:
          • Jean-Paul MIRA
        • Contact:
          • Jean-Paul MIRA
      • Paris, France
        • Not yet recruiting
        • Intensive care, University Hospital, Tenon
        • Principal Investigator:
          • Muriel FARTOUKH
        • Contact:
          • Muriel FARTOUKH
      • Poitiers, France
        • Recruiting
        • Intensive care, University Hospital, Poitiers
        • Contact:
          • Arnaud THILLE
        • Principal Investigator:
          • Arnaud THILLE
      • Rouen, France
        • Not yet recruiting
        • Intensive care, University Hospital, Rouen
        • Contact:
          • Grégoire JOLLY
        • Principal Investigator:
          • Grégoire JOLLY
      • Saint-Brieuc, France
        • Recruiting
        • Intensive care, University Hospital, Saint Brieuc
        • Contact:
          • François LEGAY
        • Principal Investigator:
          • François LEGAY
      • Saint-Nazaire, France
        • Recruiting
        • Intensive care, University Hospital, Saint Nazaire
        • Contact:
          • Patricia COUROUBLE
        • Principal Investigator:
          • Patricia COUROUBLE
      • Strasbourg, France
        • Not yet recruiting
        • Intensive care, University Hospital, Strasbourg
        • Contact:
          • Jean-Etienne HERBRECHT
        • Principal Investigator:
          • Jean-Etienne HERBRECHT
      • Tours, France
        • Recruiting
        • Intensive care, University Hospital, Tours
        • Principal Investigator:
          • Stephan EHRMANN
        • Contact:
          • Stephan EHRMANN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients admitted to an intensive care unit or intermediate care unit
  • Suspicion of community acquired pneumonia (at least one of the 3 criteria): fever, cough, purulent expectoration
  • And abnormalities suggestive of pneumonia by chest X-ray or CT-scan
  • PaO2/FiO2 ratio <300 mmHg (or equivalent SpO2/FiO2 i.e. < 315 mmHg) under a minimum gas flow of 30 L/min.
  • Person affiliated to a French social security system or equivalent
  • Informed consent.

Exclusion Criteria:

  • Positive SARS-COV2 test within the last 30 days
  • Indication for immediate intubation
  • Patients for whom a "do not intubate" decision has been made
  • Chest trauma or other contraindication to prone position
  • Patients with formal indication for non-invasive ventilation: exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary oedema.
  • Pregnant or breastfeeding woman
  • Subjects who are under legal protection measure
  • More than 8h awake prone positioning prior to inclusion
  • More than 48h since intensive care unit or intermediate care unit admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prone position group
patients will be invited and assisted to prone as long as possible every day. The goal is to achieve at least 8h in the prone position per 24h period, with 3-6 prone sessions.
Other: Prone position
depending on tolerance, the objective is to spend as much time as possible, up to 16h and beyond, in prone position per period of 24 hours. For each session the patients will be encouraged to stay as long as possible in the prone position (i.e. ideally 4-8 hours each session).
No Intervention: Control group
Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation within 28 days of randomization
Time Frame: From randomization to day 28
Analyzed in a competing risk framework with death and intensive care unit discharge taken into account as competing events.
From randomization to day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) before the first prone session for patients in the intervention group.
Time Frame: From randomization to 6 hours
From randomization to 6 hours
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) during the first prone session for patients in the intervention group.
Time Frame: From randomization to day 1
From randomization to day 1
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) after the first prone session for patients in the intervention group.
Time Frame: From randomization to day 1
From randomization to day 1
Daily patient comfort comparison between groups from day 1 to day 3, using a visual analogue scale.
Time Frame: From day 1 to day 3
From day 1 to day 3
Oxygenation (PaO2/FiO2 ratio and ROX index) daily comparison between groups from day 1 to day 3.
Time Frame: From day 1 to day 3
From day 1 to day 3
Time to treatment escalation to non-invasive ventilation or continuous positive airway pressure (CPAP) with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
Time Frame: From randomization to day 28 or intensive care unit discharge whichever occurs first
From randomization to day 28 or intensive care unit discharge whichever occurs first
Time to successful weaning of nasal high flow with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
Time Frame: From randomization to day 28 or intensive care unit discharge whichever occurs first
From randomization to day 28 or intensive care unit discharge whichever occurs first
Time to intensive care unit discharge and time to hospital discharge (up to day 28).
Time Frame: From randomization to day 28
From randomization to day 28
Mortality
Time Frame: From randomization to day 90
From randomization to day 90
Mortality
Time Frame: From randomization to day 28 or intensive care unit and hospital discharge
From randomization to day 28 or intensive care unit and hospital discharge
Nursing workload: time spent in the patient room by nursing staff during the 24 hours post randomization in both groups
Time Frame: From randomization to 24 hours post randomization
measured as person.hours
From randomization to 24 hours post randomization
Safety: skin lesions, lines dislodgement, central line infection, vomiting, (up to day 28 or intensive care unit discharge whichever occurs first).
Time Frame: From randomization to day 28 or intensive care unit discharge whichever occurs first).
From randomization to day 28 or intensive care unit discharge whichever occurs first).
Patient comfort before the first prone session, using a visual analogue scale.
Time Frame: From randomization to 6 hours
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
From randomization to 6 hours
Patient comfort during the first prone session, using a visual analogue scale.
Time Frame: From randomization to day 1
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
From randomization to day 1
Patient comfort after the first prone session, using a visual analogue scale.
Time Frame: From randomization to day 1
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
From randomization to day 1
Evolution of patient's quality of life
Time Frame: At 90 days
using the EQ-5D-5L questionnaire. The response is given on 5-point scales (1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total inability)
At 90 days
Evolution of patient's quality of life
Time Frame: At 5 years
using the EQ-5D-5L questionnaire. The response is given on 5-point scales (1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total inability)
At 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Stephan EHRMANN, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

October 1, 2034

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR230003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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