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Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | on demand humidification |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On Demand Humidification system Mark 2 | Device | The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test. |
| Measure | Description | Time Frame |
|---|---|---|
| optimum comfortable amount of on-demand humidification | questionnaire based on Borg Scale and Visual Analog scale | 3 hours |
| optimum comfortable amount of on-demand humidification | heart rate | 3 hours |
| optimum comfortable amount of on-demand humidification | breathing rate | 3 hours |
| optimum comfortable amount of on-demand humidification | SpO2 | 3 hours |
| optimum comfortable amount of on-demand humidification | transcutaneous CO2 | 3 hours |
| optimum comfortable amount of on-demand humidification | number of mucus clearance events | 3 hours |
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Inclusion Criteria:
Age > 18 of age; < 85 years of age
Participants with a neuromuscular disorder who:
Able to provide feedback/articulate via some form of communication
Patients using a Trilogy ventilator
Invasively ventilated patients that are willing to use a HME device on their way to participate in the study (from home to hospital).
Patients that are willing to participate and are able to consent and sign the informed consent form. (Patients with the functional capacity for medical decision-making).
Exclusion Criteria:
Clinically unstable, i.e.,
Patients suffering from metastatic or terminal cancer
Patients lacking the functional capacity for medical decision-making.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Netherlands |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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