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

NCT06966310 | Recruiting

• 1 other identifier: DR230003
• Study Type: interventional
• Target: 1,078
• Locations: 1 country
• Sites: 38

Brief Summary

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.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Intubation within 28 days of randomization

  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 Outcomes (17)

• Patient comfort before the first prone session, using a visual analogue scale.

  From randomization to 6 hours

• Patient comfort during the first prone session, using a visual analogue scale.

  From randomization to day 1

• Patient comfort after the first prone session, using a visual analogue scale.

  From randomization to day 1

• 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.

  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.

  From randomization to day 1

Study Arms (2)

Prone position group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning.

Interventions

Prone position OTHER

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).

Prone position group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 48h since intensive care unit or intermediate care unit admission.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (38)

Intensive care, University Hospital, Amiens

Amiens, France

NOT YET RECRUITING

Intensive care, University Hospital, Angers

Angers, France

NOT YET RECRUITING

Intensive care, University Hospital, Argenteuil

Argenteuil, France

NOT YET RECRUITING

Intensive care, University Hospital, Belfort

Belfort, France

NOT YET RECRUITING

Intensive care, University Hospital, Besancon

Besançon, France

NOT YET RECRUITING

Intensive care, University Hospital, Bethune

Béthune, France

NOT YET RECRUITING

Intensive care, University Hospital, Blois

Blois, France

NOT YET RECRUITING

Intensive care, University Hospital, Bordeaux

Bordeaux, France

NOT YET RECRUITING

Intensive care, University Hospital, Bourg en Bresse

Bourg-en-Bresse, France

NOT YET RECRUITING

Intensive care, University Hospital, Bourges

Bourges, France

RECRUITING

Intensive care, University Hospital, Brest

Brest, France

NOT YET RECRUITING

Intensive care, University Hospital, Colombes

Colombes, France

NOT YET RECRUITING

Intensive care, University Hospital, Dieppe

Dieppe, France

NOT YET RECRUITING

Intensive care, University Hospital, Dijon

Dijon, France

RECRUITING

Intensive care, University Hospital, Dreux

Dreux, France

NOT YET RECRUITING

Intensive care, University Hospital, Garches

Garche, France

NOT YET RECRUITING

Intensive care, University Hospital, Grenoble

Grenoble, France

NOT YET RECRUITING

Intensive care, University Hospital, La Roche sur Yon

La Roche-sur-Yon, France

RECRUITING

Intensive care, University Hospital, Le Mans

Le Mans, France

RECRUITING

Intensive care, University Hospital, Lens

Lens, France

RECRUITING

Intensive care, University Hospital, Lille

Lille, France

NOT YET RECRUITING

Intensive care, University Hospital, Lorient

Lorient, France

NOT YET RECRUITING

Intensive care, University Hospital, Lyon

Lyon, France

NOT YET RECRUITING

Intensive care, University Hospital, Lyon

Lyon, France

NOT YET RECRUITING

Intensive care, University Hospital, Morlaix

Morlaix, France

RECRUITING

Intensive care, University Hospital, Nantes

Nantes, France

RECRUITING

Intensive care, University Hospital, Nice

Nice, France

NOT YET RECRUITING

Intensive care, University Hospital, Nice

Nice, France

NOT YET RECRUITING

Intensive care, University Hospital, Orléans

Orléans, France

NOT YET RECRUITING

Intensive care, University Hospital, Cochin

Paris, France

NOT YET RECRUITING

Intensive care, University Hospital, Tenon

Paris, France

NOT YET RECRUITING

Intensive care, University Hospital, Poitiers

Poitiers, France

RECRUITING

Intensive care, University Hospital, Rouen

Rouen, France

NOT YET RECRUITING

Intensive care, University Hospital, Saint Brieuc

Saint-Brieuc, France

RECRUITING

Intensive care, University Hospital, Saint Nazaire

Saint-Nazaire, France

RECRUITING

Intensive care, University Hospital, Strasbourg

Strasbourg, France

NOT YET RECRUITING

Intensive care, University Hospital, Strasbourg

Strasbourg, France

NOT YET RECRUITING

Intensive care, University Hospital, Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephan EHRMANN

  University Hospital, Tours

  STUDY DIRECTOR

Central Study Contacts

Stephan EHRMANN

CONTACT

2.47.47.38.55; stephanehrmann@gmail.com

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: May 2, 2025
• First Posted: May 11, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): October 1, 2034
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (38)