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

NCT07157098 | Not Yet Recruiting

• 1 other identifier: 25-035
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypercapnic Respiratory Failure

Keywords

acute hypercapnic respiratory failure; non-invasive ventilation; high-flow oxygen

Outcome Measures

Primary Outcomes (1)

• Power of Breathing

  A marker of the patient's work of breathing. Calculated by thickening fraction of the diaphragm, multiplied by the respiratory rate.

  Minute 10, 20, and 30

Secondary Outcomes (3)

• Ventilatory Ratio

  Minute 10, 20, and 30

• Patient's comfort

  Minute 10, 20, and 30

• Patient's subjective shortness of breath

  Minute 10, 20, and 30

Study Arms (1)

All study patient

EXPERIMENTAL

Sequential respiratory support with 3 devices

Device: asymmetrical high-flow nasal cannula; Device: non-invasive ventilation with standard mask; Device: non-invasive ventilation with a new mask

Interventions

asymmetrical high-flow nasal cannula DEVICE

high-flow nasal oxygen therapy via asymmetrical nasal prongs

All study patient

non-invasive ventilation with standard mask DEVICE

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

All study patient

non-invasive ventilation with a new mask DEVICE

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

All study patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with acute hypercapnic respiratory failure
• Admitted to the intensive care unit
• Being treated with either high-flow oxygen treatment or non-invasive ventilation

You may not qualify if:

• 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).

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Nattapat Wongtirawit, M.D.

CONTACT

416-864-6060; nattapat.wongtirawit@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will go through three intervention steps, each with a different breathing support: asymmetrical high-flow nasal cannula (HFNC), non-invasive ventilation (NIV) using the standard NIV mask at the participating center, and NIV using a new mask design. Each step lasts 10 minutes.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 5, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)