Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
NCT ID: NCT06104956
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
370 participants
INTERVENTIONAL
2024-02-17
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Experimental group : Imposed weaning protocol
The flow of the HFNO will remain high (50-60 L/min) guaranteeing the effectiveness of the HFNO on the wash-out of the anatomical space. At the same time, weaning will begin with a gradual reduction in FiO2 of 0.1 every 4 hours. To achieve this reduction, the patient will have to meet the safety targets of a stable respiratory rate at rest (no increase) and pulsed oxygen saturation (SpO2). The SpO2 target will be 92-95%. Once the FiO2 has stabilised at 0.4 for 4 hours, the nurse will initiate a 10 L/min reduction in the flow of HFNO every 4 hours. The oxygen therapy support may be changed for standard oxygen when the HFNO flow rate is 40L/min with an FIO2 of 0.4 for 4 consecutive hours.
HFNO weaning protocol
Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done
Control group
Weaning methods will be left to the free choice of the practitioner. Any change in the HFNO setting must be made on medical prescription. A minimum SpO2 objective is required (SpO2 ≥92%).
HFNO Standard of care
Weaning methods will be left to the free choice of the practitioner.
Interventions
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HFNO weaning protocol
Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done
HFNO Standard of care
Weaning methods will be left to the free choice of the practitioner.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Mai-Anh NAY, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU Orléans
Locations
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Intensive care, University Hospital, Blois
Blois, , France
Intensive care unit, University Hospital, Bourg-en-Bresse
Bourg-en-Bresse, , France
Intensive care, University Hospital, Bourges
Bourges, , France
Intensive care unit, University Hospital, Caen
Caen, , France
Intensive care, University Hospital, Chartres
Chartres, , France
Intensive care, University Hospital, Cholet
Cholet, , France
Intensive care, University Hospital, Dax
Dax, , France
Intensive care, University Hospital, Le Mans,
Le Mans, , France
Intensive care, University Hospital, Orléans
Orléans, , France
Intensive care, University Hospital, Tours
Tours, , France
Intensive care unit, University Hospital, Vannes
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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Julien GROUILLE, MD
Role: primary
Salman Mohammad
Role: primary
Anna BOURREAU, MD
Role: primary
Juliette AUDIBERT, MD
Role: primary
Fabien JAROUSSEAU, MD
Role: primary
Adrien AUVET, MD
Role: primary
Mickael LANDAIS, MD
Role: primary
Mai-Anh NAY, MD
Role: primary
Sophie JACQUIER, MD
Role: primary
Agathe DELBOVE, MD
Role: primary
Other Identifiers
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DR230001
Identifier Type: -
Identifier Source: org_study_id
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