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Search / Trial NCT06104956

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

Launched by UNIVERSITY HOSPITAL, TOURS · Oct 26, 2023

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a specific method to help patients in the intensive care unit (ICU) who need high-flow nasal oxygen therapy (HFNO) to breathe better. The goal is to see if a structured plan, or protocol, for gradually reducing the use of HFNO can help more patients successfully stop using it by Day 7 of the trial. Success means that patients can breathe comfortably without HFNO for at least 48 hours and do not need other breathing support, like a mask or breathing tube.

To participate in the trial, patients must be adults who are currently receiving HFNO due to a new case of severe difficulty breathing, with specific measurements showing they are stable enough to begin the weaning process. Patients will be monitored closely throughout the study, which lasts until Day 28, to ensure their progress and safety. It’s important for potential participants and their families to know that signing consent is required, and eligibility will be determined based on certain health conditions.

Gender

ALL

Eligibility criteria

  • 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 HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, flow rate and FiO2 having to be stable (i.e. not increased) in the 24 hours prior to inclusion
  • With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88
  • 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

About University Hospital, Tours

The University Hospital of Tours, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative clinical research and patient-centered care. With a strong emphasis on collaboration between researchers, clinicians, and community partners, the hospital fosters a dynamic environment for conducting high-quality clinical trials across various medical disciplines. Its commitment to excellence in patient safety, ethical standards, and scientific integrity positions the University Hospital of Tours as a pivotal contributor to the development of new therapies and health solutions, ultimately enhancing patient outcomes and public health.

Locations

Blois, , France

Bourg En Bresse, , France

Bourges, , France

Chartres, , France

Cholet, , France

Dax, , France

Le Mans, , France

Orléans, , France

Tours, , France

Vannes, , France

Patients applied

0 patients applied

Trial Officials

Mai-Anh NAY, MD

Principal Investigator

CHRU Orléans

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported