Actively Recruiting
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
Led by University Hospital, Tours · Updated on 2025-07-30
370
Participants Needed
11
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care. The main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation. This is a open-label multicentre randomised controlled trial conducted in two parallel groups. The primary endpoint is the success rate at Day 7, with success defined as "definitive" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7. The weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.
CONDITIONS
Official Title
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient admitted to intensive care or continuous care unit for new hypoxemic acute respiratory failure with PaO2/FiO2 ratio less than 300 mmHg
- Receiving high-flow nasal oxygen therapy for at least 24 hours in intensive or continuous care
- Using HFNO with flow rate of 50 L/min or more and inspired oxygen fraction of 0.5 or higher at inclusion
- Stable or improving ROX index (SpO2/FiO2/Respiratory Rate) above 4.88 in the 6 hours before inclusion
- Blood gas test performed within 24 hours of inclusion while on HFNO
- Covered by or entitled to social security
- Provided informed consent personally or via relatives, with patient confirmation as soon as possible
You will not qualify if you...
- Presence of another patient included in the study and not weaned off HFNO in the same nurse-managed sector
- Receiving non-invasive ventilation concurrently
- Used HFNO within 7 days after extubation
- Chronic obstructive pulmonary disease at Gold grade 3 or 4
- Cardiogenic acute pulmonary edema as main cause of respiratory failure
- History of diffuse interstitial lung disease
- Long-term use of non-invasive ventilation with external positive pressure
- Long-term oxygen therapy at home
- Pregnant, in labor, or breastfeeding
- Deprived of liberty by judicial or administrative decision, hospitalized without consent, or admitted for non-research purposes
- Minor (under 18 years old)
- Subject to legal protection measures (guardianship, curatorship, court protection)
- Medical decision made not to intubate
- Previously included in this study during the same or subsequent hospital stays
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Trial Site Locations
Total: 11 locations
1
Intensive care, University Hospital, Blois
Blois, France
Actively Recruiting
2
Intensive care unit, University Hospital, Bourg-en-Bresse
Bourg-en-Bresse, France
Actively Recruiting
3
Intensive care, University Hospital, Bourges
Bourges, France
Actively Recruiting
4
Intensive care unit, University Hospital, Caen
Caen, France
Not Yet Recruiting
5
Intensive care, University Hospital, Chartres
Chartres, France
Actively Recruiting
6
Intensive care, University Hospital, Cholet
Cholet, France
Actively Recruiting
7
Intensive care, University Hospital, Dax
Dax, France
Actively Recruiting
8
Intensive care, University Hospital, Le Mans,
Le Mans, France
Actively Recruiting
9
Intensive care, University Hospital, Orléans
Orléans, France
Actively Recruiting
10
Intensive care, University Hospital, Tours
Tours, France
Actively Recruiting
11
Intensive care unit, University Hospital, Vannes
Vannes, France
Actively Recruiting
Research Team
M
Mai-Anh NAY, MD
CONTACT
M
Marie LECLERC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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