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Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)

NCT07679646 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive (COPD)
  • Hypercapnia

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Air Liquide Healthcare Spain

    lead INDUSTRY

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679646 on ClinicalTrials.gov