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

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 17, 2022

Primary Completion Date

February 1, 2025

Study Completion Date

February 1, 2025

Conditions
Acute Hypoxemic Respiratory Failure
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.

Trial Locations (11)

T2N 4N1

RECRUITING

University of Calgary, Calgary

T6G 2B7

RECRUITING

University of Alberta Hospital, Edmonton

Unknown

RECRUITING

Hamilton Health Sciences- Juravinski, Hamilton

RECRUITING

Kingston General Hospital, Kingston

RECRUITING

London Health Sciences Centre, London

RECRUITING

Mount Sinai Hospital, Toronto

RECRUITING

University Health Network Toronto General, Toronto

K1H 8L6

RECRUITING

Ottawa Hospital, Ottawa

M2K 1E1

RECRUITING

North York General Hospital, Toronto

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

M5B 1W8

RECRUITING

St. Michael's Hospital, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER