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Clinical Trial 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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05078034
Study type Interventional
Source Sunnybrook Health Sciences Centre
Contact Damon Scales, MD PhD FRCPC
Phone 416-480-5291
Email damon.scales@sunnybrook.ca
Status Recruiting
Phase N/A
Start date March 17, 2022
Completion date February 1, 2025

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