Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT06104956
Recruiting Not applicable

Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care

NCT06104956 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Tours
Phase
Not applicable
Started
2024-02-17
Last updated
2025-07-30

Condition(s) studied

Acute Hypoxemic Respiratory FailureHigh-flow Nasal Oxygen Therapy

Investigational drug(s) / intervention(s)

HFNO weaning protocolHFNO Standard of care

HFNO weaning protocol: Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done

HFNO Standard of care: Weaning methods will be left to the free choice of the practitioner.

Study 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • The success rate at Day 7 — 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.

Trial sites (11)

FacilityCityRegionStatus
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

More University Hospital, Tours trials in France

Impact of Sound Shower Music Diffusion on Family Anxiety in Intensive Care Unit Waiting Room Starting soon
Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit. Starting soon
Multiomics Approach in Adult Patients With Phenylketonuria Recruiting
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis Recruiting
Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial Starting soon

Other trials for the same condition

IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure Recruiting
Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06104956 on ClinicalTrials.gov ↗ ← All trials in France