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

Neuromuscular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289715
• Other study ID #: ICBE-2-16558
• Status: Completed
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2018
• Source: Philips Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age > 18 of age; < 85 years of age

2. Participants with a neuromuscular disorder who:

1. Require 24 hour mechanical ventilation in some form through tracheostomy, mask or mouth piece

2. Can be ambulatory for at least a few hours during the day while using a heat and moisture exchange device (HME) or no humidification

3. Can part of the day use a heated pass-over humidification system while on their ventilator (overnight, for example).

3. Able to provide feedback/articulate via some form of communication

4. Patients using a Trilogy ventilator

5. Invasively ventilated patients that are willing to use a HME device on their way to participate in the study (from home to hospital).

6. 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:

1. Clinically unstable, i.e.,

1. Acute respiratory failure

2. Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)

3. Uncontrolled cardiac ischemia or arrhythmias

4. Any participant determined as inappropriate for the study by the Principal Investigator

2. Patients suffering from metastatic or terminal cancer

3. Patients lacking the functional capacity for medical decision-making.

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Device:
• On Demand Humidification system Mark 2
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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Philips Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optimum comfortable amount of on-demand humidification	questionnaire based on Borg Scale and Visual Analog scale	3 hours
Primary	optimum comfortable amount of on-demand humidification	heart rate	3 hours
Primary	optimum comfortable amount of on-demand humidification	breathing rate	3 hours
Primary	optimum comfortable amount of on-demand humidification	SpO2	3 hours
Primary	optimum comfortable amount of on-demand humidification	transcutaneous CO2	3 hours
Primary	optimum comfortable amount of on-demand humidification	number of mucus clearance events	3 hours