Skip to main content
OpenTrials
Completed

NCT Number: NCT03289715

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuromuscular Diseases Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. optimum comfortable amount of on-demand humidification

    Time frame: 3 hours

    questionnaire based on Borg Scale and Visual Analog scale

  2. optimum comfortable amount of on-demand humidification

    Time frame: 3 hours

    heart rate

  3. optimum comfortable amount of on-demand humidification

    Time frame: 3 hours

    breathing rate

  4. optimum comfortable amount of on-demand humidification

    Time frame: 3 hours

    SpO2

  5. optimum comfortable amount of on-demand humidification

    Time frame: 3 hours

    transcutaneous CO2

  6. optimum comfortable amount of on-demand humidification

    Time frame: 3 hours

    number of mucus clearance events

Sponsors and collaborators

Lead sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2017
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.