NCT07679646Not yet recruiting
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 92 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Air Liquide Healthcare Spain
- Diseases
- COPD
- NCT number
- NCT07679646
What you commit to
- Study type: Observational
- Planned participants: 92
- From 1 Dec 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Lab values
- Advanced renal insufficiency (creatinine clearance \< 30%) or inclusion in an active dialysis program.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.