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

Philips

Status: Completed

Conditions: Neuromuscular Diseases

Treatments: Device: On Demand Humidification system Mark 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03289715

ICBE-2-16558

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

arm 1

Experimental group

Description:

on demand humidification

Treatment:

Device: On Demand Humidification system Mark 2