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RECRUITING
NCT06104956
NA

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

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2024-02-17

Completion Date

2027-03

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DRUG

HFNO weaning protocol

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

DRUG

HFNO 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