RECRUITINGOBSERVATIONAL

Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices

SAGE-NIV: Surveillance and Artificial Intelligence Guidance for Exacerbations in COPD Patients With Home Non-Invasive Ventilation

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Lack of willing to sign a consent form. - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

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

Recruitment: * Collection of the clinical variables described in the previous section. * Download the data from the commercial ventilator mentioned in the 'Inclusion criteria' section. By default, the option 'all available detailed data' is selected in the menu corresponding to the built-in software. * Contact the coordinating centre to obtain an internal study code. * Send the contents of the folder corresponding to the recruited patient to the coordinating centre (using an encrypted system). Treatment and handling of data: * The clinical data collected after anonymisation will be stored on-line using the RedCap platform (https://www.project-redcap.org/). Data downloaded from the ventilator will be identified by a random code and stored on the encrypted Proton platform (https://proton.me/es-es) or similar. * Built-in software data: Once the file has been received, the 10 days prior to the admission, which will be the reason for recruitment

Locations (1)

Corporation Parc Tauli de Sabadell

Sabadell, Barcelona, Spain