Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06104956
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2023-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
Sponsor:
University Hospital, Tours
Organization:
Study Overview
Official Title:
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HiFloWEAN
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: