Back to resultsEvaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Primary Purpose
Neuromuscular Diseases
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
On Demand Humidification system Mark 2
Sponsored by
About this trial
This is an interventional supportive care trial for Neuromuscular Diseases
Eligibility Criteria
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.
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
arm 1
Arm Description
on demand humidification
Outcomes
Primary Outcome Measures
optimum comfortable amount of on-demand humidification
questionnaire based on Borg Scale and Visual Analog scale
optimum comfortable amount of on-demand humidification
heart rate
optimum comfortable amount of on-demand humidification
breathing rate
optimum comfortable amount of on-demand humidification
SpO2
optimum comfortable amount of on-demand humidification
transcutaneous CO2
optimum comfortable amount of on-demand humidification
number of mucus clearance events
Secondary Outcome Measures
Full Information
NCT ID
NCT03289715
First Posted
September 15, 2017
Last Updated
October 9, 2018
Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
1. Study Identification
Unique Protocol Identification Number
NCT03289715
Brief Title
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Official Title
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm 1
Arm Type
Experimental
Arm Description
on demand humidification
Intervention Type
Device
Intervention Name(s)
On Demand Humidification system Mark 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
optimum comfortable amount of on-demand humidification
Description
questionnaire based on Borg Scale and Visual Analog scale
Time Frame
3 hours
Title
optimum comfortable amount of on-demand humidification
Description
heart rate
Time Frame
3 hours
Title
optimum comfortable amount of on-demand humidification
Description
breathing rate
Time Frame
3 hours
Title
optimum comfortable amount of on-demand humidification
Description
SpO2
Time Frame
3 hours
Title
optimum comfortable amount of on-demand humidification
Description
transcutaneous CO2
Time Frame
3 hours
Title
optimum comfortable amount of on-demand humidification
Description
number of mucus clearance events
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
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