Home Breathing Support With Remote Monitoring for COPD and High Blood Carbon Dioxide
Compares home ventilation with and without remote monitoring in people with COPD.
Plain-language title generated from the registry record
Registry title: Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Key facts
- Where
- Madrid, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 90 years old?
Source: NCT07679646, who can take part
Where in Spain
- Hospital General Universitario Gregorio MarañónMadrid, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Air Liquide Healthcare Spain
- Trial code
- NCT07679646
- Record updated
- 28 October 2026
- Original description
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:Read full original descriptionShow less
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia
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.
Inclusion: Age between 50 and 90 years; Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to current Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, demonstrating non-fully reversible airflow limitation with a Forced Expiratory Volume in 1 second (FEV1) < 50% of the predicted value confirmed by spirometry; Persistent hypercapnia, defined as PaCO2 > 53 mmHg documented for at least two weeks following an acute COPD exacerbation; History of two or more acute COPD exacerbations within the preceding year; Signed written informed consent.
Exclusion: Prior ongoing treatment with home non-invasive ventilation (NIV) or Continuous Positive Airway Pressure (CPAP); Hepatic cirrhosis or active inclusion in a liver transplant program; Classification by the attending physician as non-compliant with medical therapies, treatments, or study protocols; Terminal heart failure (New York Heart Association [NYHA] Class III-IV) or unstable angina; Severe psychiatric illness requiring antipsychotic medication, active ongoing treatment for substance or alcohol addiction, or lack of a fixed home address upon hospital discharge; Advanced renal insufficiency (creatinine clearance < 30%) or inclusion in an active dialysis program; Severe obstructive sleep apnea (OSA), defined as an Apnea-Hypopnea Index (AHI) >= 30; Inability of the patient or the primary caregiver to comprehend or operate the telemonitoring and NIV procedures; Estimated life expectancy of less than one year; Receipt of home palliative care; Institutionalization.