Respiratory Insufficiency Requiring Mechanical Ventilation
Conditions
Keywords
home mechanical ventilation, telemonitoring
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.
Interventions
DEVICETelemonitoring AirView (ResMed company)
Introduction of AirView telemonitoring of HMV, during a 6-months period.
Sponsors
Centre Hospitalier Régional de la Citadelle
Erasme University Hospital
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance to the treatment | T1: Mean value during night 1 (inpatient) | Hours of use of HMV/24h |
| Leaks | T1: Median value during night 1 (inpatient) | Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage. |
| AHI index | T1 : Median value during night 1 (inpatient) | The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inconfort score | T1 : Score after night 1 (inpatient) | This score (0-4 points) evaluates the discomfort of the patient using HMV. A score of zero suggests perfect comfort (none out of the 4 symptoms present) and a score of 4 (all symptoms present) suggests maximal discomfort related to the presence of the following 4 symptoms: pain or skin lesions, dryness of the mucous membranes, rhinitis or eye irritation, discomfort related to the settings of the device. |
| Algorithm Score | T2 : Score after night 2 (inpatient) | This score (0-2 points) is given by the professional assessing the algorithm effectiveness after the Airview data analysis: 0 - no or useless intervention of the carer after using the algorithm, 1 - partial positive improvement after intervention post-algorithm, 2 - clear improvement after intervention post-algorithm or no use of the algorithm because of perfect use of HMV at home. |
Countries
Belgium
Contacts
Primary ContactMichel Toussaint, PhD
Backup ContactAdrien Meunier, MSc
Outcome results
None listed