An interventional study of HFNO weaning protocol and HFNO Standard of care in Acute Hypoxemic Respiratory Failure and High-flow Nasal Oxygen Therapy, sponsored by University Hospital, Tours. Recruiting at 11 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Other
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 370 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: HFNO weaning protocol
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%).
Drug: HFNO Standard of care
Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done
Weaning methods will be left to the free choice of the practitioner.
The success rate at Day 7
Success being defined as "definitive" weaning from HFNO, i.e. a patient weaned for more than 48 hours from HFNO without recourse to non-invasive ventilation or intubation and still alive at Day 7.
Time frame: At day 7
High-flow nasal oxygen therapy (HFNO) weaning rate at day 28
Time frame: At day 28
Time to definitive weaning from HFNO
Time frame: From randomisation to day 28
Cumulative incidence of intubation
Time frame: From randomisation to day 28
Cumulative incidence of use of curative non-invasive ventilation
Time frame: From randomisation to day 28
Mortality rate at day 28
Time frame: At Day 28
Number of days on HFNO for patients definitively weaned from HFNO
Time frame: From randomisation to discharge from intensive care or at Day 28
Changes in the ROX index during the weaning phase
ROX index : \[(SpO2/FiO2)/respiratory rate\]
Time frame: From randomisation to day 28
Changes in the use of accessory respiratory muscles
Using the Patrick score (Score from 0 to 5)
Time frame: From randomisation to discharge from intensive care or to Day 28
Progression of dyspnoea
Assessed by the modified Borg scale (scale from 0 to 10)
Time frame: From randomisation to discharge from intensive care or to Day 28
Intensive care unit and/or continuous monitoring unit length of stay
Time frame: From randomization until the date of discharge, assessed up to 28 days maximum
Intensive care unit and/or continuous monitoring unit length of stay or time to ICU discharge readiness
The ability to go out will be defined by the validation of all the items on the modified ability grid (score modified from Hiller et al. ; 28 items)
Time frame: From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum
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University Hospital, Tours