SAGE-NIV: Surveillance and Artificial Intelligence Guidance for Exacerbations in COPD Patients With Home Non-Invasive Ventilation
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Corporation Parc Tauli de Sabadell
RECRUITING
Sabadell
Contact Information
Primary
Manel Lujan, Professor MD pHD
mlujan@tauli.cat
+34 937231010
Backup
Cristina Lalmolda Puyol, RT phD
clalmolda@tauli.cat
+34 692186820
Time Frame
Start Date:2025-03-25
Estimated Completion Date:2026-12
Participants
Target number of participants:75
Treatments
study cohort with COPD and NIV patients for at least 6 months
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