Actively Recruiting
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
Eligibility Criteria
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
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
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