Telemonitoring in Home Mechanical Ventilation

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation
• Intervention / Treatment: Device: Telemonitoring AirView (ResMed company)

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Michel Toussaint, PhD; Phone Number: +322555 67 54; Email: michel.toussaint@hubruxelles.be
• Study Contact Backup: Name: Adrien Meunier, MSc; Phone Number: +3243216494; Email: adrien.meunier@citadelle.be

Study Locations

• Belgium
  • Brussels, Belgium, 1420
    • Michel Toussaint

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Telemonitoring AirView (ResMed company); Introduction of AirView telemonitoring of HMV, during a 6-months period.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: Centre Hospitalier Régional de la Citadelle
• Investigators: Study Director: Geoffroy De Fooz, Dr, Citadelle Hospital; Principal Investigator: Adrien Meunier, MSc, Citadelle Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: telemonitoring; home mechanical ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Citadelle Liège project1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No