Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices (SAGE-NIV)

Corporacion Parc Tauli

Status: Enrolling

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Other: The intervention involves download data of ventilator with clinical dates of the patient and model ventilator and parameters in acute exacebartion fo COPD

Study type: Observational

Funder types: Other

Identifiers

NCT07267104

SEPAR PII-NIV (Other Grant/Funding Number)

SAGE-NIV

Details and patient eligibility

About

This study will look at people with COPD who use a home breathing machine called non-invasive ventilation (NIV). NIV machines collect information about your breathing, such as air flow, pressure, and mask leaks.

Researchers want to use a computer program, called artificial intelligence (AI), to study this information. The goal is to find early signs that your breathing may be getting worse.

People with COPD who already use NIV at home may join this study. The study does not change your treatment. It only uses the breathing data already recorded by your NIV machine.

The computer program will look for patterns in the data. These patterns may help doctors:

Notice early warning signs of a COPD flare-up Find problems with how you and the machine work together Improve the way NIV is monitored at home The main goal is to create a tool that helps patients and doctors manage home NIV more easily and more safely.

Full description

This study proposes the development of an artificial intelligence (AI) system to monitor and analyse detailed non-invasive mechanical ventilation (NIV) data in COPD patients, with the aim of predicting clinical exacerbations and improving home management.

Analysis of data from home NIV devices allows assessment of patient compliance, detection of leaks and asynchronies, and monitoring of upper airway events. However, the potential of these data to improve ventilation management in COPD patients has been limited, in part due to the lack of tools to process and interpret the detailed records. Transforming these data into an open format opens up the possibility of applying artificial intelligence to analyse large amounts of information and develop predictive models.

The multi-centre, observational, longitudinal study design will include COPD patients on NIV therapy who meet adherence criteria. Detailed leak, pressure and flow time data, previously decrypted and converted into a data format readable by analysis software, will be analysed. The identified metrics will be evaluated by machine learning algorithms using techniques such as random forest and neural networks.

Expected outcomes include the development of an automated predictive model to enable early detection of exacerbations and improved patient-ventilator synchronisation, moving towards more efficient and personalised telemonitoring in home NIV management.

Enrollment: 75 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 40 and 80 years.
• COPD diagnosed by pulmonary function tests.
• Home NIV therapy with good adherence (minimum daily compliance > 5 hours) for at least 6 months.
• Users of the ResMed LUMIS 150 ventilator. This is due to the presence of the decoding tool and a larger storage capacity (more than 100 nights) in the removable device of the ventilator.
• Acute exacerbation requiring hospital admission or home care.

Exclusion criteria

• Lack of informed consent.
• Previous clinical instability defined by the need for antibiotics and/or systemic corticosteroids in the two months prior to the inclusion exacerbation, excluding the 48 hours prior to admission, as this was considered part of the inclusion clinical picture.

Trial design

75 participants in 1 patient group

study cohort with COPD and NIV patients for at least 6 months

Description:

1. Inclusion criteria: * Age between 40 and 80 years. * COPD diagnosed by pulmonary function tests. * Home NIV therapy with good adherence (minimum daily compliance \> 5 hours) for at least 6 months. * Users of the ResMed LUMIS 150 ventilator. This is due to the presence of the decoding tool and a larger storage capacity (more than 100 nights) in the removable device of the ventilator. * Acute exacerbation requiring hospital admission or home care. 2. Exclusion criteria: * Lack of informed consent. * Previous clinical instability defined by the need for antibiotics and/or systemic corticosteroids in the two months prior to the inclusion exacerbation, excluding the 48 hours prior to admission, as this was considered part of the inclusion clinical picture. Ethical aspects: Patients will receive written information about the study and will also receive verbal explanations to clarify any doubts. Participation is voluntary and the patient may withdraw from the study at any time. No inv

Treatment:

Other: The intervention involves download data of ventilator with clinical dates of the patient and model ventilator and parameters in acute exacebartion fo COPD