Clinical trial NCT06104956: Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
Official title: Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
High-flow Nasal Oxygen Therapy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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: Inclusion Criteria:

* 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 HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, flow rate and FiO2 having to be stable (i.e. not increased) in the 24 hours prior to inclusion
* With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88
* 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:

* 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

Primary outcomes:
measure: The success rate at Day 7
timeFrame: At day 7
Secondary outcomes:
measure: High-flow nasal oxygen therapy (HFNO) weaning rate at day 28
timeFrame: At day 28
measure: Time to definitive weaning from HFNO
timeFrame: From randomisation to day 28
measure: Cumulative incidence of intubation
timeFrame: From randomisation to day 28
measure: Cumulative incidence of use of curative non-invasive ventilation
timeFrame: From randomisation to day 28
measure: Mortality rate at day 28
timeFrame: At Day 28
measure: Number of days on HFNO for patients definitively weaned from HFNO
timeFrame: From randomisation to discharge from intensive care or at Day 28
measure: Changes in the ROX index during the weaning phase
timeFrame: From randomisation to day 28
measure: Changes in the use of accessory respiratory muscles
timeFrame: From randomisation to discharge from intensive care or to Day 28
measure: Progression of dyspnoea
timeFrame: From randomisation to discharge from intensive care or to Day 28
measure: Intensive care unit and/or continuous monitoring unit length of stay
timeFrame: From randomization until the date of discharge, assessed up to 28 days maximum
measure: Intensive care unit and/or continuous monitoring unit length of stay or time to ICU discharge readiness
timeFrame: From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum
Other outcomes:
Locations:
city: Blois
country: France
facility: Intensive care, University Hospital, Blois
city: Bourg-en-Bresse
country: France
facility: Intensive care unit, University Hospital, Bourg-en-Bresse
city: Bourges
country: France
facility: Intensive care, University Hospital, Bourges
city: Chartres
country: France
facility: Intensive care, University Hospital, Chartres
city: Cholet
country: France
facility: Intensive care, University Hospital, Cholet
city: Dax
country: France
facility: Intensive care, University Hospital, Dax
city: Le Mans
country: France
facility: Intensive care, University Hospital, Le Mans,
city: Orléans
country: France
facility: Intensive care, University Hospital, Orléans
city: Tours
country: France
facility: Intensive care, University Hospital, Tours
city: Vannes
country: France
facility: Intensive care unit, University Hospital, Vannes
Study officials:
affiliation: CHRU Orléans
name: Mai-Anh NAY, MD
role: PRINCIPAL_INVESTIGATOR
References: