Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital, Tours
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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)
Trial design
Treatments tested in this trial
- HFNO weaning protocol
- HFNO Standard of care
Treatment groups
370 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov