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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study patient | Experimental | Sequential respiratory support with 3 devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asymmetrical high-flow nasal cannula | Device | high-flow nasal oxygen therapy via asymmetrical nasal prongs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Minute 10, 20, and 30 |
| Patient's comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nattapat Wongtirawit, M.D. | Contact | 416-864-6060 | 6214 | nattapat.wongtirawit@unityhealth.to |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
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.
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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.
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| 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 |
|
Obtained from a visual analog scale from 1 to 10, with 10 indicating the highest comfort |
| 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 | Minute 10, 20, and 30 |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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