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NCT Number: NCT06104956

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

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.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure High-Flow Nasal Oxygen Therapy Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive care, University Hospital, Blois, Blois, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFNO weaning protocol

Drug

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

HFNO Standard of care

Drug

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

Primary outcomes

  1. The success rate at Day 7

    Time frame: 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.

Secondary outcomes

  1. High-flow nasal oxygen therapy (HFNO) weaning rate at day 28

    Time frame: At day 28

  2. Time to definitive weaning from HFNO

    Time frame: From randomisation to day 28

  3. Cumulative incidence of intubation

    Time frame: From randomisation to day 28

  4. Cumulative incidence of use of curative non-invasive ventilation

    Time frame: From randomisation to day 28

  5. Mortality rate at day 28

    Time frame: At Day 28

  6. Number of days on HFNO for patients definitively weaned from HFNO

    Time frame: From randomisation to discharge from intensive care or at Day 28

  7. Changes in the ROX index during the weaning phase

    Time frame: From randomisation to day 28

    ROX index : [(SpO2/FiO2)/respiratory rate]

  8. Changes in the use of accessory respiratory muscles

    Time frame: From randomisation to discharge from intensive care or to Day 28

    Using the Patrick score (Score from 0 to 5)

  9. Progression of dyspnoea

    Time frame: From randomisation to discharge from intensive care or to Day 28

    Assessed by the modified Borg scale (scale from 0 to 10)

  10. Intensive care unit and/or continuous monitoring unit length of stay

    Time frame: From randomization until the date of discharge, assessed up to 28 days maximum

  11. Intensive care unit and/or continuous monitoring unit length of stay or time to ICU discharge readiness

    Time frame: From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Mai-Anh NAY, MD

CONTACT

[email protected]

02.38.51.44.46 ext. +33

Marie LECLERC

CONTACT

[email protected]

02.47.47.46.64 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: HiFloWEAN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2023
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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