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

NCT ID: NCT03289715

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2018-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

arm 1

on demand humidification

Group Type: EXPERIMENTAL

On Demand Humidification system Mark 2

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

ICBE-2-16558

Identifier Type: -

Identifier Source: org_study_id