Protocol for weaning patients off high-flow nasal oxygen therapy in intensive care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a structured weaning protocol for patients receiving high-flow nasal oxygen therapy (HFNO) in intensive care units. It aims to determine if implementing this protocol increases the likelihood of successfully weaning patients from HFNO by Day 7 post-randomization. The trial is an open-label, multicenter, randomized controlled trial with two parallel groups, focusing on patients with acute hypoxemic respiratory failure. The primary endpoint is defined as patients being weaned from HFNO for over 48 hours without needing non-invasive ventilation or intubation, while still being alive at Day 7.

Why it matters

Who can join: the full rules

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

Where it's running

• 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, University Hospital, Chartres
  Chartres, France Recruiting
• Intensive care, University Hospital, Cholet
  Cholet, France Recruiting
• Intensive care, University Hospital, Dax
  Dax, France Recruiting

Study contacts

• Principal investigator: Mai-Anh NAY, MD — CHRU Orléans
• Study coordinator: Mai-Anh NAY, MD
• Email: mai-anh.nay@chr-orleans.fr
• Phone: 02.38.51.44.46

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing oxygen therapies for patients with acute respiratory failure

  This study is testing which of three oxygen therapies—CPAP, high-flow nasal oxygen, or non-invasive ventilation—works best to help adults with severe breathing problems avoid needing a breathing tube.

  Recruiting Southeast University, China · Nanjing, Jiangsu · NCT06795971

• Predicting HFNC Failure in Acute Hypoxemic Respiratory Failure using Metabolomics and Clinical Data

  This study tests whether metabolomic blood profiles combined with routine clinical data can predict which adults with acute hypoxemic respiratory failure on high-flow nasal cannula will fail and need escalation of care.

  Recruiting Hospital del Mar Research Institute (IMIM) · Barcelona, Catalonia · NCT07607080

• Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure

  This study tests whether allowing spontaneous breathing or using controlled ventilation is better for adults with acute hypoxemic respiratory failure who need invasive mechanical ventilation.

  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07463885

• Predicting HFNO failure within 72 hours using a physiology-informed model at 30 minutes

  This study tests a model that uses Heart–lung physiology and 30-minute data to see if high-flow nasal oxygen will fail in adults with acute hypoxemic respiratory failure.

  Recruiting Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07366541

• IL-6 guided dexamethasone or tocilizumab treatment for hospitalized acute hypoxemic respiratory failure

  This study will test whether measuring IL-6 to guide early treatment with dexamethasone or tocilizumab helps adults hospitalized with new acute hypoxemic respiratory failure.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07334379

• How changing PEEP affects breathing drive and effort during pressure‑support ventilation

  We will test whether changing PEEP levels changes neural respiratory drive and inspiratory effort in adults on pressure‑support ventilation for moderate‑to‑severe ARDS or acute hypoxemic respiratory failure.

  Recruiting Radboud University Medical Center · Nijmegen, Gelderland · NCT07203781

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.