Telemonitoring in Home Mechanical Ventilation

NCT ID: NCT06143384

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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Multicentric, observational and longitudinal prospective evaluation of build-in-software data telemonitoring of home ventilators in patients using Home Mechanical Ventilation in Belgium.

Detailed Description

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OBJECTIVES : Use of a decisional algorithm (developed by La Citadelle/Liège) to assess Telemonitoring (AirView type, ResMed) of data in the ventilators of patients using Home Mechanical Ventilation (HMV), and registered in the Belgian agreement for HMV at 1/ the Citadelle hospital in Liège and 2/HUB-Erasme, Brussels, Belgium.

BACKGROUND: HMV initiated in the hospital is used at home. Patients who benefit from HMV present significant functional limitations of cardio-respiratory, neurological and/or physical origin. Such limitations compromise the ability of patients to travel to the referring hospital. As a result, good treatment follow-up is difficult to assess both from quantity and quality points of view. This is why Telemonitoring systems have been developed to access ventilator build-in-software data at through dedicated online systems. In other words, data from devices operating at home can be sent to the hospital and analyzed in real time by professionnals in the hospital. This project aims to evaluate the impact of Telemonitoring ventilator's data on the quality of HMV-monitoring in patients living and using HMV at home.

METHODS: A one-year multicentric, observational, longitudinal and prospective evaluation of build-in-software data telemonitoring of home ventilators in patients using HMV in Belgium. The two Belgian hospitals will each follow 10 patients for one year (2024). The data from the ventilator as well as the actions to be taken in response to Airview Telemonitoring alerts will be carried out using a decision-making algorithm created by the Citadelle Hospital in Liège.

Conditions

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Respiratory Insufficiency Requiring Mechanical Ventilation

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients using Home Mechanical Ventilation (HMV)

Patients using Home Mechanical Ventilation (HMV), and registered in the Belgian agreement for HMV at 1/ the Citadelle hospital in Liège, Belgium and 2/HUB-Erasme hospital, Brussels, Belgium.

Telemonitoring AirView (ResMed company)

Intervention Type DEVICE

Introduction of AirView telemonitoring of HMV, during a 6-months period.

Interventions

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Telemonitoring AirView (ResMed company)

Introduction of AirView telemonitoring of HMV, during a 6-months period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients starting HMV in 2024, followed up in 1/ Liège or 2/ Brussels, and using devices from the ResMed company (Astral 150 ou Lumis 150).

Exclusion Criteria

* Individuals refusing to sign the consent form
* Presence of acute pathology requiring hospitalization and close monitoring of ventilation
* Patients using a tracheostomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Régional de la Citadelle

OTHER

Sponsor Role collaborator

Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michel Toussaint

Coordinator Center for Home Mechanical Ventilation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geoffroy De Fooz, Dr

Role: STUDY_DIRECTOR

Citadelle Hospital

Adrien Meunier, MSc

Role: PRINCIPAL_INVESTIGATOR

Citadelle Hospital

Locations

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Michel Toussaint

Brussels, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Michel Toussaint, PhD

Role: CONTACT

+322555 67 54

Adrien Meunier, MSc

Role: CONTACT

+3243216494

Other Identifiers

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Citadelle Liège project1

Identifier Type: -

Identifier Source: org_study_id