Telemonitoring in Home Mechanical Ventilation

Study Overview
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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.

Official Title
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Benefits of Telemonitoring in Home Mechanical Ventilation by the Use of a Simple and Intuitive Algorithm

Conditions
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Respiratory Insufficiency Requiring Mechanical Ventilation

Intervention / Treatment
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* Device: Telemonitoring AirView (ResMed company)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients using Home Mechanical Ventilation (HMV)<br>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. | Device: Telemonitoring AirView (ResMed company)<br>* Introduction of AirView telemonitoring of HMV, during a 6-months period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to the treatment | Hours of use of HMV/24h | T1: Mean value during night 1 (inpatient) | 
| Compliance to the treatment | Hours of use of HMV/24h | T2: Mean value during night 2 (inpatient) | 
| Compliance to the treatment | Hours of use of HMV/24h | T3: Mean value during nights 24-30 (outpatient) | 
| Compliance to the treatment | Hours of use of HMV/24h | T4: Mean value during nights 174-180 (outpatient) | 
| Leaks | Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage. | T1: Median value during night 1 (inpatient) | 
| Leaks | Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage. | T2: Median value during nights 2 (inpatient) | 
| Leaks | Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage. | T3: Median value during nights 24-30 (outpatient) | 
| Leaks | Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage. | T4: Median value during nights 174-180 (outpatient) | 
| AHI index | The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV. | T1 : Median value during night 1 (inpatient) | 
| AHI index | The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV. | T2: Median value during night 2 (inpatient) | 
| AHI index | The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV. | T3: Median value during nights 24-30 (outpatient) | 
| AHI index | The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV. | T4: Median value during nights 174-180 (outpatient) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inconfort score | 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. | T1 : Score after night 1 (inpatient) | 
| Inconfort score | 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. | T2 : Score after night 2 (inpatient) | 
| Inconfort score | 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. | T3 : Score after nights 24-30 (outpatient) | 
| Inconfort score | 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. | T4 : Score after nights 174-180 (outpatient) | 
| Algorithm Score | 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. | T2 : Score after night 2 (inpatient) | 
| Algorithm Score | 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. | T3 : Score after nights 24-30 (outpatient) | 
| Algorithm Score | 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. | T4 : Score after night 2 (outpatient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home mechanical ventilation, telemonitoring