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.
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.
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.
The study population consists of adult patients diagnosed with severe, stable Chronic Obstructive Pulmonary Disease (COPD) and chronic persistent hypercapnia, who are managed and followed at public university hospitals within the Community of Madrid, Spain, and who have a recent history of frequent acute respiratory exacerbations.
Cohort
Prospective
Home Non-Invasive Ventilation and Telemonitoring
DeviceUse 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.
Number of prevented days of hospitalization due to COPD acute exacerbations
The total number of days a patient spends hospitalized in a general hospital ward or Intensive Care Unit (ICU) due to acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). An acute exacerbation is defined according to GOLD criteria as an increase in dyspnea, cough, and/or sputum worsening in less than 14 days.
Health-Related Quality of Life and Utility (QALYs)
Measured using the validated Spanish version of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. It evaluates 2 continuous components: the Visual Analogue Scale (VAS, scored 0-100) and the EQ-Index (scored 0-1, where 1 represents perfect health and 0 represents death). These scores will be utilized to calculate Quality-Adjusted Life Years (QALYs) gained.
Number of Acute COPD Exacerbations
Total count of localized respiratory worsening events matching the GOLD definition (worsening of dyspnea, cough, or sputum) experienced by patients during the study.
Number of Hospital Admissions due to COPD Exacerbations
Total number of formal hospital admissions required due to severe acute respiratory deteriorations.
Number of Emergency Department Visit
Total count of unexpected visits to hospital emergency rooms or primary care emergency facilities necessitated by acute COPD flare-ups.
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