Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation

Conditions
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Neuromuscular Diseases

Intervention / Treatment
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* Device: On Demand Humidification system Mark 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 of age; < 85 years of age Participants with a neuromuscular disorder who: Require 24 hour mechanical ventilation in some form through tracheostomy, mask or mouth piece Can be ambulatory for at least a few hours during the day while using a heat and moisture exchange device (HME) or no humidification Can part of the day use a heated pass-over humidification system while on their ventilator (overnight, for example). 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., Acute respiratory failure Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents) Uncontrolled cardiac ischemia or arrhythmias Any participant determined as inappropriate for the study by the Principal Investigator Patients suffering from metastatic or terminal cancer Patients lacking the functional capacity for medical decision-making.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm 1<br>on demand humidification | Device: On Demand Humidification system Mark 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |