Clinical trial NCT06143384: Telemonitoring in Home Mechanical Ventilation
Official title: Benefits of Telemonitoring in Home Mechanical Ventilation by the Use of a Simple and Intuitive Algorithm
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation
Keywords: home mechanical ventilation
telemonitoring
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Régional de la Citadelle
First posted: 2023-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients requiring noninvasive ventilation at home and followed-up in Liège or Brussels hospitals, as previously described.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance to the treatment
timeFrame: T1: Mean value during night 1 (inpatient)
measure: Compliance to the treatment
timeFrame: T2: Mean value during night 2 (inpatient)
measure: Compliance to the treatment
timeFrame: T3: Mean value during nights 24-30 (outpatient)
measure: Compliance to the treatment
timeFrame: T4: Mean value during nights 174-180 (outpatient)
measure: Leaks
timeFrame: T1: Median value during night 1 (inpatient)
measure: Leaks
timeFrame: T2: Median value during nights 2 (inpatient)
measure: Leaks
timeFrame: T3: Median value during nights 24-30 (outpatient)
measure: Leaks
timeFrame: T4: Median value during nights 174-180 (outpatient)
measure: AHI index
timeFrame: T1 : Median value during night 1 (inpatient)
measure: AHI index
timeFrame: T2: Median value during night 2 (inpatient)
measure: AHI index
timeFrame: T3: Median value during nights 24-30 (outpatient)
measure: AHI index
timeFrame: T4: Median value during nights 174-180 (outpatient)
Secondary outcomes:
measure: Inconfort score
timeFrame: T1 : Score after night 1 (inpatient)
measure: Inconfort score
timeFrame: T2 : Score after night 2 (inpatient)
measure: Inconfort score
timeFrame: T3 : Score after nights 24-30 (outpatient)
measure: Inconfort score
timeFrame: T4 : Score after nights 174-180 (outpatient)
measure: Algorithm Score
timeFrame: T2 : Score after night 2 (inpatient)
measure: Algorithm Score
timeFrame: T3 : Score after nights 24-30 (outpatient)
measure: Algorithm Score
timeFrame: T4 : Score after night 2 (outpatient)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Michel Toussaint
Study officials:
affiliation: Citadelle Hospital
name: Geoffroy De Fooz, Dr
role: STUDY_DIRECTOR
affiliation: Citadelle Hospital
name: Adrien Meunier, MSc
role: PRINCIPAL_INVESTIGATOR
References: