Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT05078034
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Study Overview
Official Title:
High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)
Status:
RECRUITING
Status Verified Date:
2024-04
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:
HONOUR
Brief Summary:
This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).
Detailed Description:
This is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with AHRF who are admitted to the intensive care unit. Patients with imminent need for intubation, or a contraindication to study interventions will be excluded. Patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet NIV oxygen interspersed with HFNO or (2) HFNO alone over at least 2 calendar days. Participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after enrolment.
Study Oversight
Has Oversight DMC:
True
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?: