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

ConditionAcute Hypercapnic Respiratory Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with acute hypercapnic respiratory failure

Admitted to the intensive care unit

Being treated with either high-flow oxygen treatment or non-invasive ventilation

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: All study patientExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
Minute 10, 20, and 30

Secondary outcomes

1

Ventilatory Ratio

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)

Time frame
Minute 10, 20, and 30
2

Patient's comfort

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

Time frame
Minute 10, 20, and 30
3

Patient's subjective shortness of breath

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

Time frame
Minute 10, 20, and 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: