What is this study trying to find out about acute hypoxemic respiratory failure?

This study is evaluating whether a specific weaning protocol helps patients in intensive care stop using high-flow nasal oxygen therapy (HFNO) by Day 7. Researchers want to see if following this protocol improves the chance of successful weaning compared to standard care. The University Hospital, Tours is leading the study to improve treatment management for patients with acute respiratory failure.

Who may be eligible for this acute hypoxemic respiratory failure clinical trial?

Adults aged 18 to 90 years who are receiving HFNO with a high flow and oxygen level and have acute hypoxemic respiratory failure may be eligible. Participants must not be currently using non-invasive ventilation or have recent HFNO use after extubation. People with very severe lung disease or certain heart conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this acute hypoxemic respiratory failure clinical trial?

Study-related care, including the study treatment and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered. Participants can expect their care related to the trial to be free while other costs depend on individual circumstances.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 90Years

All Genders

ID06104956

Protocol to Wean Adults From High-flow Nasal Oxygen Therapy in Intensive Care A Multicenter Randomized Controlled Study

Led by University Hospital, Tours · Updated on 2025-07-30

370

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a weaning protocol for patients in intensive care who are receiving high-flow nasal oxygen therapy HFNO due to acute hypoxemic respiratory failure. The study aims to find out if following this protocol increases the chances that patients can be successfully weaned off HFNO by Day 7 after randomization. This open-label, multicenter randomized controlled trial compares the new weaning protocol with standard care, focusing on patients who meet certain stability and oxygenation criteria before starting weaning. Participants in the experimental group will have their HFNO settings gradually reduced according to a specific algorithm. The flow will initially remain high while the oxygen concentration FiO2 is decreased every 4 hours if safety targets for respiratory rate and oxygen saturation SpO2 between 92-95% are met. Once FiO2 stabilizes at 0.4, the flow rate is then decreased stepwise every 4 hours. When the flow reaches 40 Lmin and FiO2 is 0.4 for 4 hours, oxygen support may be switched to standard oxygen. In the control group, weaning methods are determined by the treating practitioner. All changes require medical prescription and aim to maintain a minimum SpO2 of 92%. During the study, patients will be monitored up to 28 days, with assessments including respiratory parameters, oxygen use, and safety outcomes. The primary outcome is the rate of successful weaning off HFNO at Day 7, defined as more than 48 hours without HFNO, non-invasive ventilation, or intubation, and survival at Day 7. Secondary outcomes include time to weaning, rates of intubation and non-invasive ventilation, mortality at Day 28, respiratory muscle use, dyspnea progression, and length of intensive care stay. The study includes adults aged 18 to 90 years admitted for new acute respiratory failure and treated with HFNO at high flow and oxygen settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 90Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 90 years
Admitted for new acute hypoxemic respiratory failure with PaO2/FiO2 ratio below 300 mmHg
Receiving high-flow nasal oxygen therapy (HFNO) for at least 24 hours in intensive or continuous care
HFNO settings at inclusion: flow rate at least 50 L/min and FiO2 of 0.5 or higher
ROX index stable or improving above 4.88 in the 6 hours before inclusion
Blood gas test done under HFNO within 24 hours before inclusion
Covered by or entitled to social security
Provided informed consent or consent given by relatives if patient unable, to be confirmed later

You will not qualify if you...

Another patient in the same nurse's sector already enrolled and not weaned off HFNO
Receiving non-invasive ventilation currently
HFNO used within 7 days after extubation
Severe chronic obstructive pulmonary disease (Gold grade 3 or 4)
Cardiogenic acute pulmonary edema as main cause of respiratory failure
History of diffuse interstitial lung disease
On long-term non-invasive ventilation with external positive pressure
On long-term home oxygen therapy
Pregnant, in labor, or breastfeeding
Deprived of liberty by judicial or administrative decision or hospitalized without consent
Minor
Subject to legal protection measures (guardianship, curatorship, court protection)
Medical decision not to intubate
Previously included in this study during the same or a prior stay

Research Team

Mai-Anh NAY, MD

Marie LECLERC

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Protocol to Wean Adults From High-flow Nasal Oxygen Therapy in Intensive Care A Multicenter Randomized Controlled Study

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria