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

NCT06104956 | Recruiting

• 1 other identifier: DR230001
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Acute Hypoxemic Respiratory Failure; High-flow Nasal Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

Experimental group : Imposed weaning protocol

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

HFNO weaning protocol DRUG

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

Experimental group : Imposed weaning protocol

HFNO Standard of care DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (11)

Intensive care, University Hospital, Blois

Blois, France

RECRUITING

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

Bourg-en-Bresse, France

RECRUITING

Intensive care, University Hospital, Bourges

Bourges, France

RECRUITING

Intensive care unit, University Hospital, Caen

Caen, France

NOT YET RECRUITING

Intensive care, University Hospital, Chartres

Chartres, France

RECRUITING

Intensive care, University Hospital, Cholet

Cholet, France

RECRUITING

Intensive care, University Hospital, Dax

Dax, France

RECRUITING

Intensive care, University Hospital, Le Mans,

Le Mans, France

RECRUITING

Intensive care, University Hospital, Orléans

Orléans, France

RECRUITING

Intensive care, University Hospital, Tours

Tours, France

RECRUITING

Intensive care unit, University Hospital, Vannes

Vannes, France

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Mai-Anh NAY, MD

  CHRU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mai-Anh NAY, MD

CONTACT

02.38.51.44.46; mai-anh.nay@chr-orleans.fr

Marie LECLERC

CONTACT

02.47.47.46.64; m.leclerc@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 27, 2023
• Study Start: February 17, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

FR (11)