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

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Device: On Demand Humidification system Mark 2

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: arm 1; on demand humidification

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: ICBE-2-16558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No