Status:
COMPLETED
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Lead Sponsor:
Philips Electronics Nederland B.V. acting through Philips CTO organization
Conditions:
Neuromuscular Diseases
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03289715
Start Date
January 12 2018
End Date
July 31 2018
Last Update
October 10 2018
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands