Protocol for weaning patients off high-flow nasal oxygen therapy in intensive care
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial
This study is testing a new plan to help patients in intensive care who are on high-flow nasal oxygen therapy breathe on their own again by Day 7.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 11 sites (Blois and 10 other locations) |
| Trial ID | NCT06104956 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a structured weaning protocol for patients receiving high-flow nasal oxygen therapy (HFNO) in intensive care units. It aims to determine if implementing this protocol increases the likelihood of successfully weaning patients from HFNO by Day 7 post-randomization. The trial is an open-label, multicenter, randomized controlled trial with two parallel groups, focusing on patients with acute hypoxemic respiratory failure. The primary endpoint is defined as patients being weaned from HFNO for over 48 hours without needing non-invasive ventilation or intubation, while still being alive at Day 7.
Who should consider this trial
Good fit: Ideal candidates are adults admitted to intensive care for acute hypoxemic respiratory failure who are currently receiving stable high-flow nasal oxygen therapy.
Not a fit: Patients who are already on non-invasive ventilation or those who cannot be weaned off HFNO will not benefit from this study.
Why it matters
Potential benefit: If successful, this protocol could improve patient outcomes by increasing the rate of successful weaning from HFNO in critically ill patients.
How similar studies have performed: While the approach of using a weaning protocol for HFNO is common, the specific protocol being tested in this study may provide novel insights into its effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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 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: * 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
Where this trial is running
Blois and 10 other locations
- Intensive care, University Hospital, Blois — Blois, France (Recruiting)
- Intensive care unit, University Hospital, Bourg-en-Bresse — Bourg-en-Bresse, France (Recruiting)
- Intensive care, University Hospital, Bourges — Bourges, France (Recruiting)
- Intensive care unit, University Hospital, Caen — Caen, France (Not_yet_recruiting)
- Intensive care, University Hospital, Chartres — Chartres, France (Recruiting)
- Intensive care, University Hospital, Cholet — Cholet, France (Recruiting)
- Intensive care, University Hospital, Dax — Dax, France (Recruiting)
- Intensive care, University Hospital, Le Mans, — Le Mans, France (Recruiting)
- Intensive care, University Hospital, Orléans — Orléans, France (Recruiting)
- Intensive care, University Hospital, Tours — Tours, France (Recruiting)
- Intensive care unit, University Hospital, Vannes — Vannes, France (Recruiting)
Study contacts
- Principal investigator: Mai-Anh NAY, MD — CHRU Orléans
- Study coordinator: Mai-Anh NAY, MD
- Email: mai-anh.nay@chr-orleans.fr
- Phone: 02.38.51.44.46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.