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ACTIVE NOT RECRUITING
NCT05078034
NA

HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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