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

Starting soon

Conditions studied: Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

In brief

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.

Key facts

Study ID

NCT07679646

Run by

Air Liquide Healthcare Spain

People needed

92

Starts

2026-07-01

Expected to finish

2026-12-01

Last updated by the study team

2026-07-01

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior ongoing treatment with home non-invasive ventilation (NIV) or Continuous Positive Airway Pressure (CPAP).
• 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.
• Terminal heart failure (New York Heart Association [NYHA] Class III-IV) or unstable angina.
• Advanced renal insufficiency (creatinine clearance < 30%) or inclusion in an active dialysis program.
• Hepatic cirrhosis or active inclusion in a liver transplant program.
• Severe psychiatric illness requiring antipsychotic medication, active ongoing treatment for substance or alcohol addiction, or lack of a fixed home address upon hospital discharge.
• Receipt of home palliative care.
• Institutionalization.
• Classification by the attending physician as non-compliant with medical therapies, treatments, or study protocols

Where it is running

• Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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