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

Not Applicable

Not yet recruiting

• Conditions: Acute Hypercapnic Respiratory Failure

• Registration Number: NCT07157098
• Lead Sponsor: Unity Health Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study Start: 2025-08-25
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-06
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Power of Breathing	Minute 10, 20, and 30	A marker of the patient's work of breathing. Calculated by thickening fraction of the diaphragm, multiplied by the respiratory rate.

Secondary Outcome Measures

Name	Time	Method
Ventilatory Ratio	Minute 10, 20, and 30	A marker of ventilation efficiency. Calculated from carbon dioxide level (in this case, obtained from transcutaneous capnography) and minute ventilation (in this case, obtained from electrical impedance tomography)
Patient's comfort	Minute 10, 20, and 30	Obtained from a visual analog scale from 1 to 10, with 10 indicating the highest comfort
Patient's subjective shortness of breath	Minute 10, 20, and 30	Obtained from a visual analog scale from 1 to 10, with 10 indicating the worst shortness of breath

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada