Telemonitoring in Home Mechanical Ventilation

Sponsor
Erasme University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06143384
Collaborator
Centre Hospitalier Régional de la Citadelle (Other)
20
1
12
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Benefits of Telemonitoring in Home Mechanical Ventilation by the Use of a Simple and Intuitive Algorithm
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Compliance to the treatment [T1: Mean value during night 1 (inpatient)]

    Hours of use of HMV/24h

  2. Compliance to the treatment [T2: Mean value during night 2 (inpatient)]

    Hours of use of HMV/24h

  3. Compliance to the treatment [T3: Mean value during nights 24-30 (outpatient)]

    Hours of use of HMV/24h

  4. Compliance to the treatment [T4: Mean value during nights 174-180 (outpatient)]

    Hours of use of HMV/24h

  5. Leaks [T1: Median value during night 1 (inpatient)]

    Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.

  6. Leaks [T2: Median value during nights 2 (inpatient)]

    Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.

  7. Leaks [T3: Median value during nights 24-30 (outpatient)]

    Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.

  8. Leaks [T4: Median value during nights 174-180 (outpatient)]

    Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.

  9. AHI index [T1 : Median value during night 1 (inpatient)]

    The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.

  10. AHI index [T2: Median value during night 2 (inpatient)]

    The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.

  11. AHI index [T3: Median value during nights 24-30 (outpatient)]

    The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.

  12. AHI index [T4: Median value during nights 174-180 (outpatient)]

    The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.

Secondary Outcome Measures

  1. 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.

  2. Inconfort score [T2 : Score after night 2 (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.

  3. Inconfort score [T3 : Score after nights 24-30 (outpatient)]

    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.

  4. Inconfort score [T4 : Score after nights 174-180 (outpatient)]

    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.

  5. 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.

  6. Algorithm Score [T3 : Score after nights 24-30 (outpatient)]

    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.

  7. Algorithm Score [T4 : Score after night 2 (outpatient)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Michel Toussaint Brussels Belgium 1420

Sponsors and Collaborators

  • Erasme University Hospital
  • Centre Hospitalier Régional de la Citadelle

Investigators

  • Study Director: Geoffroy De Fooz, Dr, Citadelle Hospital
  • Principal Investigator: Adrien Meunier, MSc, Citadelle Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michel Toussaint, Coordinator Center for Home Mechanical Ventilation, Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT06143384
Other Study ID Numbers:
  • Citadelle Liège project1
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michel Toussaint, Coordinator Center for Home Mechanical Ventilation, Erasme University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2023