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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
370
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.
Intensive care, University Hospital, Blois
Blois, France
RECRUITINGIntensive care unit, University Hospital, Bourg-en-Bresse
Bourg-en-Bresse, France
RECRUITINGIntensive care, University Hospital, Bourges
Bourges, France
RECRUITINGIntensive care unit, University Hospital, Caen
Caen, France
NOT_YET_RECRUITINGIntensive care, University Hospital, Chartres
Chartres, France
RECRUITINGIntensive care, University Hospital, Cholet
Cholet, France
RECRUITINGIntensive care, University Hospital, Dax
Dax, France
RECRUITINGIntensive care, University Hospital, Le Mans,
Le Mans, France
RECRUITINGIntensive care, University Hospital, Orléans
Orléans, France
RECRUITINGIntensive care, University Hospital, Tours
Tours, France
RECRUITING...and 1 more locations
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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