Status:
RECRUITING
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
Lead Sponsor:
University Hospital, Tours
Conditions:
Acute Hypoxemic Respiratory Failure
High-flow Nasal Oxygen Therapy
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 hig...
Eligibility Criteria
Inclusion
- Major patient admitted to the intensive care unit or continuous care unit for de novo hypoxaemic acute respiratory failure (with a PaO2/FiO2 ratio \<300 mmHg)
- Treated with HDNO for at least 24 hours in an intensive care unit or continuous care unit
- Treated with HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion
- With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in a worsening phase).
- Had a blood gas test under HFNO within 24 hours of inclusion
- Participant covered by or entitled to social security
- Informed consent signed by the patient or its relatives if the patient is incapable; this consent must then be confirmed by the patient as soon as possible
Exclusion
- Presence of a patient included in the study and not weaned off HFNO in the sector managed by the nurse of the patient assessed for eligibility
- Concomitant non-invasive ventilation treatment
- Use of HFNO within 7 days of extubation
- Chronic obstructive pulmonary disease (Gold grade 3 or 4)
- Cardiogenic acute pulmonary oedema as the main cause of acute respiratory failure
- Diffuse interstitial lung disease as a medical history
- Patient with long-term non-invasive ventilation with external positive pressure
- Patient on long-term oxygen therapy at home
- Pregnant women, women in labour and breastfeeding mothers
- Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
- Minor
- Adult subject to a legal protection measure (guardianship, curators, person under court protection)
- Patient with a medical decision not to intubate
- Patients already included in the study, neither for the same stay if they were to present the inclusion criteria again, nor for subsequent stays
Key Trial Info
Start Date :
February 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06104956
Start Date
February 17 2024
End Date
March 1 2027
Last Update
July 30 2025
Active Locations (11)
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1
Intensive care, University Hospital, Blois
Blois, France
2
Intensive care unit, University Hospital, Bourg-en-Bresse
Bourg-en-Bresse, France
3
Intensive care, University Hospital, Bourges
Bourges, France
4
Intensive care unit, University Hospital, Caen
Caen, France