Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06966310

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

Led by University Hospital, Tours · Updated on 2026-05-04

1078

Participants Needed

38

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position (lying face down) while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients admitted to an intensive care unit or intermediate care unit
  • Suspected community acquired pneumonia with at least one symptom: fever, cough, or purulent expectoration
  • Chest X-ray or CT scan showing pneumonia
  • PaO2/FiO2 ratio less than 300 mmHg or SpO2/FiO2 less than 315 mmHg with gas flow of at least 30 L/min
  • Affiliated to a French social security system or equivalent
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Positive COVID-19 test within the last 30 days
  • Need for immediate intubation
  • "Do not intubate" decision in place
  • Chest trauma or contraindication to prone positioning
  • Formal indication for non-invasive ventilation due to COPD exacerbation or acute cardiogenic pulmonary edema
  • Pregnant or breastfeeding women
  • Under legal protection measures
  • More than 8 hours of awake prone positioning before inclusion
  • More than 48 hours since admission to intensive or intermediate care unit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 28 days or until discharge from intensive care unit

Participants receive nasal high flow therapy and are either assisted to spend as much time as possible in the prone position daily or receive usual care without prone positioning.

Daily visits while receiving therapy

Follow-up

Duration - Up to 5 years

Participants are followed for outcomes including mortality and quality of life after treatment ends.

Follow-up visits at 90 days and at 5 years

Trial Site Locations

Total: 38 locations

1

Intensive care, University Hospital, Amiens

Amiens, France

Not Yet Recruiting

2

Intensive care, University Hospital, Angers

Angers, France

Not Yet Recruiting

3

Intensive care, University Hospital, Argenteuil

Argenteuil, France

Not Yet Recruiting

4

Intensive care, University Hospital, Belfort

Belfort, France

Not Yet Recruiting

5

Intensive care, University Hospital, Besancon

Besançon, France

Not Yet Recruiting

6

Intensive care, University Hospital, Bethune

Béthune, France

Not Yet Recruiting

7

Intensive care, University Hospital, Blois

Blois, France

Not Yet Recruiting

8

Intensive care, University Hospital, Bordeaux

Bordeaux, France

Not Yet Recruiting

9

Intensive care, University Hospital, Bourg en Bresse

Bourg-en-Bresse, France

Not Yet Recruiting

10

Intensive care, University Hospital, Bourges

Bourges, France

Actively Recruiting

11

Intensive care, University Hospital, Brest

Brest, France

Not Yet Recruiting

12

Intensive care, University Hospital, Colombes

Colombes, France

Not Yet Recruiting

13

Intensive care, University Hospital, Dieppe

Dieppe, France

Not Yet Recruiting

14

Intensive care, University Hospital, Dijon

Dijon, France

Actively Recruiting

15

Intensive care, University Hospital, Dreux

Dreux, France

Not Yet Recruiting

16

Intensive care, University Hospital, Garches

Garche, France

Not Yet Recruiting

17

Intensive care, University Hospital, Grenoble

Grenoble, France

Not Yet Recruiting

18

Intensive care, University Hospital, La Roche sur Yon

La Roche-sur-Yon, France

Actively Recruiting

19

Intensive care, University Hospital, Le Mans

Le Mans, France

Actively Recruiting

20

Intensive care, University Hospital, Lens

Lens, France

Actively Recruiting

21

Intensive care, University Hospital, Lille

Lille, France

Not Yet Recruiting

22

Intensive care, University Hospital, Lorient

Lorient, France

Not Yet Recruiting

23

Intensive care, University Hospital, Lyon

Lyon, France

Not Yet Recruiting

24

Intensive care, University Hospital, Lyon

Lyon, France

Not Yet Recruiting

25

Intensive care, University Hospital, Morlaix

Morlaix, France

Actively Recruiting

26

Intensive care, University Hospital, Nantes

Nantes, France

Actively Recruiting

27

Intensive care, University Hospital, Nice

Nice, France

Not Yet Recruiting

28

Intensive care, University Hospital, Nice

Nice, France

Not Yet Recruiting

29

Intensive care, University Hospital, Orléans

Orléans, France

Not Yet Recruiting

30

Intensive care, University Hospital, Cochin

Paris, France

Not Yet Recruiting

31

Intensive care, University Hospital, Tenon

Paris, France

Not Yet Recruiting

32

Intensive care, University Hospital, Poitiers

Poitiers, France

Actively Recruiting

33

Intensive care, University Hospital, Rouen

Rouen, France

Not Yet Recruiting

34

Intensive care, University Hospital, Saint Brieuc

Saint-Brieuc, France

Actively Recruiting

35

Intensive care, University Hospital, Saint Nazaire

Saint-Nazaire, France

Actively Recruiting

36

Intensive care, University Hospital, Strasbourg

Strasbourg, France

Not Yet Recruiting

37

Intensive care, University Hospital, Strasbourg

Strasbourg, France

Not Yet Recruiting

38

Intensive care, University Hospital, Tours

Tours, France

Actively Recruiting

Loading map...

Research Team

S

Stephan EHRMANN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Effect of Acyclovir Therapy on the Outcome of Ventilated Pat...

Pneumonia, Viral

Actively Recruiting

28 locations

Amoxicillin Alone Versus Amoxicillin/Clavulanate for Communi...

Community-acquired Pneumonia

Actively Recruiting

19 locations

AntiThrombotic Therapy to Ameliorate Clinical Complications ...

Community-acquired Pneumonia

Actively Recruiting

64 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here