MedTrace Logo

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

NCT06104956 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2025-07-30

No results posted yet for this study

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

Interventions

DRUG

HFNO weaning protocol

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

DRUG

HFNO Standard of care

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

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Mai-Anh NAY, MD · CHRU Orléans

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-17
Primary Completion
2027-02-28
Completion
2027-03-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06104956 on ClinicalTrials.gov