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

NCT03289715 | Completed

• 1 other identifier: ICBE-2-16558
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

arm 1

EXPERIMENTAL

on demand humidification

Device: On Demand Humidification system Mark 2

Interventions

On Demand Humidification system Mark 2 DEVICE

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.

arm 1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 21, 2017
• Study Start: January 12, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)