NCT07157098

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Hypercapnic Respiratory Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: Canada