An interventional study of asymmetrical high-flow nasal cannula and non-invasive ventilation with standard mask in Acute Hypercapnic Respiratory Failure, sponsored by Unity Health Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 24 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
high-flow nasal oxygen therapy via asymmetrical nasal prongs
non-invasive ventilation with standard oronasal mask, clinically used in the participting site
non-invasive ventilation with a new mask design, with under-nose, bridge-free design
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
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
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
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
Plan to share: No — The datasets generated and/or analyzed during the current study are not publicly available due participant confidentiality, according to the REB, but are available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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