Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Sponsor: Air Liquide Healthcare Spain
Summary
The purpose of this study is to evaluate the effectiveness and clinical efficiency of combining home non-invasive ventilation (NIV) with a continuous remote telemonitoring (TM) system in patients with Chronic Obstructive Pulmonary Disease (COPD) and persistent hypercapnia. In standard practice, patients with severe COPD and high carbon dioxide levels in their blood are treated with home non-invasive ventilation to support their breathing. This study compares two different care strategies over a one-year follow-up period: 1. One group of patients will receive standard home non-invasive ventilation alone. 2. Another group will receive home non-invasive ventilation combined with an automated telemonitoring system that tracks device parameters daily (such as air leaks, device usage, and breathing rates) and sends automated alerts to the healthcare team if deviations occur. The main goal of the project is to determine if adding a telemonitoring follow-up system can prevent clinical worsenings and significantly reduce the total number of days patients spend hospitalized due to severe COPD flare-ups. Additionally, the study will analyze the impact of both strategies on patients' overall health-related quality of life and the economic costs within the healthcare system.
Official title: Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia
Key Details
Gender
All
Age Range
50 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
92
Start Date
2026-07
Completion Date
2026-12
Last Updated
2026-07-01
Healthy Volunteers
No
Interventions
Home Non-Invasive Ventilation and Telemonitoring
Use of nocturnal home non-invasive ventilation devices equipped with or without integrated digital modems for automated parameter monitoring (compliance, leaks, residual AHI, respiratory rate, and tidal volume) over a 12-month follow-up period.
Locations (1)
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain