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

NCT07157098 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07157098 on ClinicalTrials.gov