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NOT YET RECRUITING
NCT07157098
NA

Asymmetrical High Flow Oxygen Versus Noninvasive Ventilation in Acute Hypercapnic Respiratory Failure

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

Summary

NIV is a life-saving treatment for people with breathing failure and carbon dioxide (CO2) retention. It helps remove this waste gas from the lungs and reduces the effort needed to breathe. However, the standard masks used for NIV can become uncomfortable over time, which may lead patients to stop using them. Stopping treatment can be dangerous and may cause breathing problems to worsen. That's why finding devices that are more comfortable and possibly more effective is very important. This study aims to take a first step in that direction. This is the first study comparing new devices designed to help people with chronic CO2 buildup during breathing flare-ups. Devices tested include a new type of asymmetrical nasal cannula for high-flow oxygen therapy and a new mask called OptiNIV, which has a comfortable design that may help remove more CO2. These devices will be compared to standard NIV masks currently used in hospitals. Outcome of interests include their effects on the effort needed to breathe, on how much CO2 is cleared, and on how comfortable they are.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-25

Completion Date

2026-07

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

DEVICE

asymmetrical high-flow nasal cannula

high-flow nasal oxygen therapy via asymmetrical nasal prongs

DEVICE

non-invasive ventilation with standard mask

non-invasive ventilation with standard oronasal mask, clinically used in the participting site

DEVICE

non-invasive ventilation with a new mask

non-invasive ventilation with a new mask design, with under-nose, bridge-free design

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada