NCT06104956

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-02-17
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2023-10-27
• Last updated: 2025-07-30

Locations

11 sites across 1 country: France