NCT06143384

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

Same day

First QC Date

November 14, 2023

Last Update Submit

November 16, 2023

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation

Keywords

home mechanical ventilationtelemonitoring

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (7)

  • Inconfort score

    T1 : Score after night 1 (inpatient)

  • Inconfort score

    T2 : Score after night 2 (inpatient)

  • Inconfort score

    T3 : Score after nights 24-30 (outpatient)

  • Inconfort score

    T4 : Score after nights 174-180 (outpatient)

  • Algorithm Score

    T2 : Score after night 2 (inpatient)

  • +2 more secondary outcomes

Study Arms (1)

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)

Interventions

Telemonitoring AirView (ResMed company)DEVICE

Introduction of AirView telemonitoring of HMV, during a 6-months period.

Patients using Home Mechanical Ventilation (HMV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients requiring noninvasive ventilation at home and followed-up in Liège or Brussels hospitals, as previously described.

You may qualify if:

  • 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).

You may not qualify if:

  • Individuals refusing to sign the consent form
  • Presence of acute pathology requiring hospitalization and close monitoring of ventilation
  • Patients using a tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michel Toussaint

Brussels, 1420, Belgium

Location

Study Officials

  • Geoffroy De Fooz, Dr

    Citadelle Hospital

    STUDY DIRECTOR

  • Adrien Meunier, MSc

    Citadelle Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Toussaint, PhD

CONTACT

+322555 67 54michel.toussaint@hubruxelles.be

Adrien Meunier, MSc

CONTACT

+3243216494adrien.meunier@citadelle.be

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator Center for Home Mechanical Ventilation

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 22, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2024

Study Completion

December 31, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)