🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Canada / NCT07157098
Starting soon Not applicable

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

NCT07157098 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-08-25
Last updated
2025-09-05

Condition(s) studied

Acute Hypercapnic Respiratory Failure

Investigational drug(s) / intervention(s)

asymmetrical high-flow nasal cannulanon-invasive ventilation with standard masknon-invasive ventilation with a new mask

asymmetrical high-flow nasal cannula: high-flow nasal oxygen therapy via asymmetrical nasal prongs

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosed with acute hypercapnic respiratory failure * Admitted to the intensive care unit * Being treated with either high-flow oxygen treatment or non-invasive ventilation Exclusion Criteria: * Clinical instability - defined as the presence of one of the followings: respiratory rate \> 40 breaths/minute, SpO2 \< 80%, active broncho-pleural fistula, Glasgow Coma Scale \< 8, mean arterial pressure below 60 mmHg despite usage of vasopressors * Requiring immediate need of endotracheal intubation, according to the judgement of the attending physician * Contraindications of monitoring with electrical impedance tomography (e.g. pacemaker, chest wall burns wounds limiting electrode placement).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
St. Michael's Hospital Toronto Ontario

More Unity Health Toronto trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157098 on ClinicalTrials.gov ↗ ← All trials in Canada