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

Last updated: July 25, 2025
Sponsor: University Hospital, Tours
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

HFNO Standard of care

Standard of care

HFNO weaning protocol

Clinical Study ID

NCT06104956
DR230001
  • Ages 18-90
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Major patient admitted to the intensive care unit or continuous care unit for denovo 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 careunit

  • 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 hoursprior to inclusion and greater than 4.88 (the patient must not be in a worseningphase).

  • 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

Exclusion Criteria:

  • Presence of a patient included in the study and not weaned off HFNO in the sectormanaged 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, personshospitalised without consent and persons admitted to a health or socialestablishment for purposes other than research.

  • Minor

  • Adult subject to a legal protection measure (guardianship, curators, person undercourt protection)

  • Patient with a medical decision not to intubate

  • Patients already included in the study, neither for the same stay if they were topresent the inclusion criteria again, nor for subsequent stays

Study Design

Total Participants: 370
Treatment Group(s): 3
Primary Treatment: HFNO Standard of care
Phase:
Study Start date:
February 17, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Intensive care, University Hospital, Blois

    Blois,
    France

    Active - Recruiting

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

    Bourg-en-Bresse,
    France

    Active - Recruiting

  • Intensive care, University Hospital, Bourges

    Bourges,
    France

    Active - Recruiting

  • Intensive care unit, University Hospital, Caen

    Caen,
    France

    Site Not Available

  • Intensive care, University Hospital, Chartres

    Chartres,
    France

    Active - Recruiting

  • Intensive care, University Hospital, Cholet

    Cholet,
    France

    Active - Recruiting

  • Intensive care, University Hospital, Dax

    Dax,
    France

    Active - Recruiting

  • Intensive care, University Hospital, Le Mans,

    Le Mans,
    France

    Active - Recruiting

  • Intensive care, University Hospital, Orléans

    Orléans,
    France

    Active - Recruiting

  • Intensive care, University Hospital, Tours

    Tours,
    France

    Active - Recruiting

  • Intensive care unit, University Hospital, Vannes

    Vannes,
    France

    Active - Recruiting

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