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NCT Number: NCT07157098

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

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.

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Key information

Conditions

Acute Hypercapnic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location contact

Nattapat Wongtirawit, MD

CONTACT

[email protected]

4168646060 ext. 6214

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

asymmetrical high-flow nasal cannula

Device

high-flow nasal oxygen therapy via asymmetrical nasal prongs

non-invasive ventilation with standard mask

Device

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

non-invasive ventilation with a new mask

Device

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

Primary outcomes

  1. Power of Breathing

    Time frame: 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 outcomes

  1. Ventilatory Ratio

    Time frame: 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)

  2. Patient's comfort

    Time frame: Minute 10, 20, and 30

    Obtained from a visual analog scale from 1 to 10, with 10 indicating the highest comfort

  3. Patient's subjective shortness of breath

    Time frame: Minute 10, 20, and 30

    Obtained from a visual analog scale from 1 to 10, with 10 indicating the worst shortness of breath

Study contacts

Contact information is provided by the study sponsor or research team.

Nattapat Wongtirawit, M.D.

CONTACT

[email protected]

416-864-6060 ext. 6214

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Acronym: HIFOLD2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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