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Mathematical Analysis of Signals and Clinical Parameters Provided by Non-invasive Home Ventilation Devices
Sponsor: Corporacion Parc Tauli
Summary
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.
Official title: SAGE-NIV: Surveillance and Artificial Intelligence Guidance for Exacerbations in COPD Patients With Home Non-Invasive Ventilation
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2025-03-25
Completion Date
2026-12
Last Updated
2025-12-05
Healthy Volunteers
No
Interventions
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