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HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
Sponsor: Sunnybrook Health Sciences Centre
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).
Official title: High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-03-17
Completion Date
2026-08
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Helmet Non-Invasive Ventilation (HNIV)
HNIV will be connected to a ventilator by a conventional closed respiratory circuit. Sessions of HNIV will be delivered with PEEP targeting a minimum 12 hours/day. PEEP will be titrated according to patient comfort, work of breathing, and O2 saturation. Pressure support will be titrated to lowest level tolerated. Between HNIV sessions, patients will be supported with HFNO at the same required FiO2. Starting on study day 3, patients will be screened for discontinuation of HNIV. Once HNIV is stopped, patients will be transitioned to HFNO and then weaned from HFNO as tolerated.
High Flow Nasal Oxygen
HFNO will be provided. FiO2 will be titrated to achieve a target O2 saturation of 92-97%, and flows will be initiated at 50 litres/minute and titrated as per usual practice for comfort and oxygenation. Once the target O2 saturation is achieved, the FiO2 will be titrated to the minimal value to maintain this target saturation. HFNO will be provided continuously over a minimum of 2 calendar days. Starting on study day 3, patients will be weaned from HFNO as tolerated.
Locations (11)
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences- Juravinski
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network Toronto General
Toronto, Ontario, Canada