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This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order;
Participants will have their physiological respiratory parameters recorded.
This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute respiratory failure will be approached for the study within the first 24 hours on NIV therapy.
The study will be conducted as described above. After the study patients will be able to choose which mask they continue their NIV on. They will continue NIV as part of their normal hospital care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive ventilation (CPAP or bilevel) with the Vela investigational mask for 1 hour | Experimental | Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. |
|
| Noninvasive ventilation (CPAP or bilevel) with the standard mask (Nivairo) for 1 hour | Active Comparator | Pressure settings for noninvasive ventilation to be set as required to provide optimal respiratory support for each patient. Not to be changed during the 2 hours of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vela Investigational Mask | Device | Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in respiratory rate | The change in patient's respiratory rate over the 1 hour of the study arm | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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No IPD will be shared with other researchers.
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Crossover study where each participant receives NIV on the Vela investigational mask and the Nivairo standard mask for one hour each in random order.
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NIV masks can not be masked during the treatments. Only the analysis will be masked.
| Nivairo Standard Mask | Device | Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy. |
|