RecruitingNot ApplicableNCT06104956

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

Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial


Sponsor

University Hospital, Tours

Enrollment

370 participants

Start Date

Feb 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two ways to wean patients off high-flow nasal oxygen (a method of delivering extra oxygen through the nose at high speeds) in the intensive care unit after acute respiratory failure, to find the safest and most effective weaning approach. **You may be eligible if...** - You are an adult admitted to the ICU with sudden, severe low blood oxygen (acute respiratory failure) - You have been on high-flow nasal oxygen for at least 24 hours - You are currently receiving high-flow oxygen at ≥50 L/min and ≥50% oxygen concentration - Your breathing and oxygen levels have been stable or improving for the past 6 hours **You may NOT be eligible if...** - You are also receiving non-invasive mechanical ventilation at the same time - You were recently taken off a breathing machine (within 7 days of extubation) - You have severe COPD (chronic obstructive pulmonary disease, Gold grade 3 or 4) - Your main cause of respiratory failure is heart-related fluid in the lungs - You have a severe, diffuse lung disease (like pulmonary fibrosis) - You are on long-term home oxygen or home non-invasive ventilation - You are pregnant or breastfeeding - You have a medical decision stating you should not be intubated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHFNO weaning protocol

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

DRUGHFNO Standard of care

Weaning methods will be left to the free choice of the practitioner.


Locations(11)

Intensive care, University Hospital, Blois

Blois, France

Intensive care unit, University Hospital, Bourg-en-Bresse

Bourg-en-Bresse, France

Intensive care, University Hospital, Bourges

Bourges, France

Intensive care unit, University Hospital, Caen

Caen, France

Intensive care, University Hospital, Chartres

Chartres, France

Intensive care, University Hospital, Cholet

Cholet, France

Intensive care, University Hospital, Dax

Dax, France

Intensive care, University Hospital, Le Mans,

Le Mans, France

Intensive care, University Hospital, Orléans

Orléans, France

Intensive care, University Hospital, Tours

Tours, France

Intensive care unit, University Hospital, Vannes

Vannes, France

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NCT06104956


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