Respiratory Insufficiency Requiring Mechanical VentilationNCT06143384
Telemonitoring in Home Mechanical Ventilation
An observational study of Respiratory Insufficiency Requiring Mechanical Ventilation, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Multicentric, observational and longitudinal prospective evaluation of build-in-software data telemonitoring of home ventilators in patients using Home Mechanical Ventilation in Belgium. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Insufficiency Requiring Mechanical Ventilation
- What is being tested?
- Telemonitoring AirView (ResMed company)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients requiring noninvasive ventilation at home and followed-up in Liège or Brussels hospitals, as previously described.
Who may be able to join
- 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).
Who cannot join
- Individuals refusing to sign the consent form
- Presence of acute pathology requiring hospitalization and close monitoring of ventilation
- Patients using a tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Telemonitoring AirView (ResMed company)
- Keywords
- home mechanical ventilation, telemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring AirView (ResMed company)Device
Introduction of AirView telemonitoring of HMV, during a 6-months period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Telemonitoring AirView (ResMed company) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to the treatment
Hours of use of HMV/24h
Measured: T1: Mean value during night 1 (inpatient)
Compliance to the treatment
Hours of use of HMV/24h
Measured: T2: Mean value during night 2 (inpatient)
Compliance to the treatment
Hours of use of HMV/24h
Measured: T3: Mean value during nights 24-30 (outpatient)
Compliance to the treatment
Hours of use of HMV/24h
Measured: T4: Mean value during nights 174-180 (outpatient)
Leaks
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
Measured: T1: Median value during night 1 (inpatient)
Leaks
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
Measured: T2: Median value during nights 2 (inpatient)
Leaks
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
Measured: T3: Median value during nights 24-30 (outpatient)
Leaks
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
Measured: T4: Median value during nights 174-180 (outpatient)
AHI index
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
Measured: T1 : Median value during night 1 (inpatient)
AHI index
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
Measured: T2: Median value during night 2 (inpatient)
AHI index
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
Measured: T3: Median value during nights 24-30 (outpatient)
AHI index
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
Measured: T4: Median value during nights 174-180 (outpatient)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T4 : Score after night 2 (outpatient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency Requiring Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle
- Responsible party
- Principal investigator, Michel Toussaint, Erasme University Hospital
- Investigators
- Geoffroy De Fooz, Dr, Study director, Citadelle HospitalAdrien Meunier, MSc, Principal investigator, Citadelle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143384
- Sponsor's protocol ID
- Citadelle Liège project1
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Telemonitoring in Home Mechanical Ventilation by the Use of a Simple and Intuitive Algorithm
- ClinicalTrials.gov ID
- NCT06143384
- Acronym / sponsor ID
- Citadelle Liège project1
- Keywords
- home mechanical ventilation, telemonitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients using Home Mechanical Ventilation (HMV) | – | Device: Telemonitoring AirView (ResMed company)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring noninvasive ventilation at home and followed-up in Liège or Brussels hospitals, as previously described.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- Individuals refusing to sign the consent form
- Presence of acute pathology requiring hospitalization and close monitoring of ventilation
- Patients using a tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring AirView (ResMed company)Introduction of AirView telemonitoring of HMV, during a 6-months period. | Device | Patients using Home Mechanical Ventilation (HMV) |
Primary outcome
Compliance to the treatment
Time frame: T1: Mean value during night 1 (inpatient)
Hours of use of HMV/24h
Compliance to the treatment
Time frame: T2: Mean value during night 2 (inpatient)
Hours of use of HMV/24h
Compliance to the treatment
Time frame: T3: Mean value during nights 24-30 (outpatient)
Hours of use of HMV/24h
Compliance to the treatment
Time frame: T4: Mean value during nights 174-180 (outpatient)
Hours of use of HMV/24h
Leaks
Time frame: T1: Median value during night 1 (inpatient)
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
Leaks
Time frame: T2: Median value during nights 2 (inpatient)
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
Leaks
Time frame: T3: Median value during nights 24-30 (outpatient)
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
Leaks
Time frame: T4: Median value during nights 174-180 (outpatient)
Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.
AHI index
Time frame: T1 : Median value during night 1 (inpatient)
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
AHI index
Time frame: T2: Median value during night 2 (inpatient)
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
AHI index
Time frame: T3: Median value during nights 24-30 (outpatient)
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
AHI index
Time frame: T4: Median value during nights 174-180 (outpatient)
The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.
7 secondary outcomes
Inconfort score
Time frame: T1 : Score after night 1 (inpatient)
Inconfort score
Time frame: T2 : Score after night 2 (inpatient)
Inconfort score
Time frame: T3 : Score after nights 24-30 (outpatient)
Inconfort score
Time frame: T4 : Score after nights 174-180 (outpatient)
Algorithm Score
Time frame: T2 : Score after night 2 (inpatient)
Algorithm Score
Time frame: T3 : Score after nights 24-30 (outpatient)
Algorithm Score
Time frame: T4 : Score after night 2 (outpatient)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffroy De Fooz, Dr study director
Citadelle Hospital
Adrien Meunier, MSc principal investigator
Citadelle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency Requiring Mechanical Ventilation, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Toussaint, PhD (+322555 67 54, michel.toussaint@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to the treatment (time frame: T1: Mean value during night 1 (inpatient)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.