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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Hypoxemic Respiratory Failure; High-flow Nasal Oxygen Therapy
• Intervention / Treatment: Drug: HFNO weaning protocol; Drug: HFNO Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 370
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai-Anh NAY, MD; Phone Number: +33 02.38.51.44.46; Email: mai-anh.nay@chr-orleans.fr
• Study Contact Backup: Name: Marie LECLERC; Phone Number: +33 02.47.47.46.64; Email: m.leclerc@chu-tours.fr

Study Locations

• France
  • Blois, France
    • Recruiting
    • Intensive care, University Hospital, Blois
    • Contact: Julien GROUILLE, MD
    • Principal Investigator: Julien GROUILLE
  • Bourg-en-Bresse, France
    • Recruiting
    • Intensive care unit, University Hospital, Bourg-en-Bresse
    • Contact: Salman Mohammad
    • Principal Investigator: Salman MOHAMMAD
  • Bourges, France
    • Recruiting
    • Intensive care, University Hospital, Bourges
    • Contact: Anna BOURREAU, MD
    • Principal Investigator: Anna BOURREAU
  • Caen, France
    • Not yet recruiting
    • Intensive care unit, University Hospital, Caen
    • Contact: Pierrick BAUDUIN; Phone Number: 0662885851; Email: bauduin-p@chu-caen.fr
    • Principal Investigator: Pierrick BAUDUIN
  • Chartres, France
    • Recruiting
    • Intensive care, University Hospital, Chartres
    • Contact: Juliette AUDIBERT, MD
    • Principal Investigator: Juliette AUDIBERT
  • Cholet, France
    • Recruiting
    • Intensive care, University Hospital, Cholet
    • Contact: Fabien JAROUSSEAU, MD
    • Principal Investigator: Fabien JAROUSSEAU
  • Dax, France
    • Recruiting
    • Intensive care, University Hospital, Dax
    • Contact: Adrien AUVET, MD
    • Principal Investigator: Adrien AUVET
  • Le Mans, France
    • Recruiting
    • Intensive care, University Hospital, Le Mans,
    • Contact: Mickael LANDAIS, MD
    • Principal Investigator: Mickael LANDAIS
  • Orléans, France
    • Recruiting
    • Intensive care, University Hospital, Orléans
    • Contact: Mai-Anh NAY, MD
    • Principal Investigator: Mai-Anh NAY
  • Tours, France
    • Recruiting
    • Intensive care, University Hospital, Tours
    • Contact: Sophie JACQUIER, MD
    • Principal Investigator: Sophie JACQUIER
  • Vannes, France
    • Recruiting
    • Intensive care unit, University Hospital, Vannes
    • Contact: Agathe Delbove, MD
    • Principal Investigator: Agathe DELBOVE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Weaning methods will be left to the free choice of the practitioner. Any change in the HFNO setting must be made on medical prescription. A minimum SpO2 objective is required (SpO2 ≥92%).	Drug: HFNO Standard of care; Weaning methods will be left to the free choice of the practitioner.
Experimental: Experimental group : Imposed weaning protocol; The flow of the HFNO will remain high (50-60 L/min) guaranteeing the effectiveness of the HFNO on the wash-out of the anatomical space. At the same time, weaning will begin with a gradual reduction in FiO2 of 0.1 every 4 hours. To achieve this reduction, the patient will have to meet the safety targets of a stable respiratory rate at rest (no increase) and pulsed oxygen saturation (SpO2). The SpO2 target will be 92-95%. Once the FiO2 has stabilised at 0.4 for 4 hours, the nurse will initiate a 10 L/min reduction in the flow of HFNO every 4 hours. The oxygen therapy support may be changed for standard oxygen when the HFNO flow rate is 40L/min with an FIO2 of 0.4 for 4 consecutive hours.	Drug: HFNO weaning protocol; Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate 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.	At day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-flow nasal oxygen therapy (HFNO) weaning rate at day 28		At day 28
Time to definitive weaning from HFNO		From randomisation to day 28
Cumulative incidence of intubation		From randomisation to day 28
Cumulative incidence of use of curative non-invasive ventilation		From randomisation to day 28
Mortality rate at day 28		At Day 28
Number of days on HFNO for patients definitively weaned from HFNO		From randomisation to discharge from intensive care or at Day 28
Changes in the ROX index during the weaning phase	ROX index : [(SpO2/FiO2)/respiratory rate]	From randomisation to day 28
Changes in the use of accessory respiratory muscles	Using the Patrick score (Score from 0 to 5)	From randomisation to discharge from intensive care or to Day 28
Progression of dyspnoea	Assessed by the modified Borg scale (scale from 0 to 10)	From randomisation to discharge from intensive care or to Day 28
Intensive care unit and/or continuous monitoring unit length of stay		From randomization until the date of discharge, assessed up to 28 days maximum
Intensive care unit and/or continuous monitoring unit length of stay or time to ICU discharge readiness	The ability to go out will be defined by the validation of all the items on the modified ability grid (score modified from Hiller et al. ; 28 items)	From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Mai-Anh NAY, MD, CHRU Orléans

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: DR230001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No