An observational study in Pulmonary Disease, Chronic Obstructive (COPD) and Hypercapnia, sponsored by Air Liquide Healthcare Spain. Not yet recruiting at 1 site in Spain. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Air Liquide Healthcare Spain (part of Air Liquide) · Observational
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:
Background and Rationale:
Chronic Obstructive Pulmonary Disease (COPD) with persistent hypercapnia is associated with increased mortality, functional decline, and high healthcare costs. While home non-invasive ventilation (NIV) is established as standard care to correct chronic respiratory failure, integrating remote telemonitoring (TM) presents an opportunity to implement early clinical interventions by allowing continuous oversight of ventilator parameters.
Study Design and Setting:
This is a prospective, multicenter, comparative cohort study with an integrated economic and utility evaluation. The study will be conducted across 5 public university hospitals within the Community of Madrid, Spain. A total of 92 patients (46 patients in the NIV+TM cohort and 46 in the conventional NIV cohort).
Study Hypotheses:
Description of Cohorts and Follow-up Interventions:
Patients receive identical advanced pressure-controlled nocturnal NIV settings but without remote data monitoring capabilities. Follow-up follows conventional guidelines based on standard clinical dependence: monthly home visits for patients requiring >12 hours/day of ventilation, or quarterly home visits for those requiring ≤12 hours/day. Compliance data, air leaks, and adaptation are checked manually during these visits. In-person follow-ups, EQ-5D-5L, and SRI assessments occur at baseline, day 30, and regular domiciliary visits, alongside mandatory arterial blood gas monitoring at 3, 6, and 12 months to verify treatment efficacy.
Economic and Data Analysis:
Analytical evaluations will be performed on an intention-to-treat basis. Clinical outcomes, utility values (Quality-Adjusted Life Years - QALYs gained calculated via Spanish EQ-5D-5L utility weights), and direct medical/non-medical healthcare system costs (utilizing the most recent official public tariffs from the Madrid Health Service - SERMAS) will be combined. Incremental Cost-Effectiveness Ratios (ICER), Incremental Cost-Utility Ratios (ICUR), and Incremental Cost-Benefit ratios will be constructed to evaluate healthcare efficiency. Uncertainty will be addressed via a deterministic sensitivity analysis assessing baseline, best-case, and worst-case scenarios for the telemonitoring implementation.
We have updated the Study Description to remove the term 'randomly allocated' to avoid misunderstanding. This is a strictly observational study where participants receive interventions (NIV or NIV+TM) as part of routine medical care based on institutional availability and clinical criteria, not by investigator assignment. To minimize selection bias inherent to the observational nature of the study, a consecutive sampling methodology and a post-hoc matching or adjusted statistical analysis using a block-restrictive system based on clinical variables was utilized, ensuring the investigator does not prospectively assign interventions.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 92 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Air Liquide Healthcare Spain is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Compared within Pulmonary Disease, Chronic Obstructive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients managed with a combined strategy consisting of advanced pressure-controlled nocturnal home non-invasive ventilation (NIV) and continuous remote telemonitoring (TM). Device compliance, residual Apnea-Hypopnea Index (AHI), air leaks, respiratory rate, and tidal volume are monitored daily. High-priority automated alerts trigger a standardized clinical decision algorithm, requiring immediate telephone triage or parameter modifications.
Device: Home Non-Invasive Ventilation and Telemonitoring
Patients managed with conventional home non-invasive ventilation (NIV) following standard follow-up guidelines based on clinical dependence, without remote telemonitoring or automatic alert systems. Compliance and leak data are verified manually during scheduled domiciliary visits (monthly or quarterly depending on daily ventilation hours).
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.
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.
Time frame: 12 months
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.
Time frame: Baseline, 30 days, 90 days, 180 days, 270 days, and 365 days.
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.
Time frame: 12 months
Number of Hospital Admissions due to COPD Exacerbations
Total number of formal hospital admissions required due to severe acute respiratory deteriorations.
Time frame: 12 months
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.
Time frame: 12 months
Time to first acute COPD exacerbation
The specific time period (measured in days) elapsed from the baseline treatment initiation until the documentation of the patient's first acute COPD exacerbation event.
Time frame: Up to 12 months
Direct Healthcare Costs
Total direct medical and non-medical healthcare resources consumed per patient (including non-invasive ventilation service costs, telemonitoring setup, emergency visits, and hospitalization days in regular wards or ICU), calculated by applying official public healthcare tariffs from the Madrid Health Service (SERMAS).
Time frame: 12 months
Plan to share: No — Individual participant data will not be shared externally due to strict patient confidentiality, data privacy, and legal regulations. In compliance with Spanish Organic Law 3/2018 (GDPR implementation) and the Patient Autonomy Law 41/2002, the link between patient identity and their study code is exclusively known and held by their attending physician[cite: 660, 685, 690, 691]. All clinical data collected are managed within a closed, pseudonymized centralized electronic platform (ReseaArch®) under a strict role-based access control architecture. External distribution of raw individual datasets is neither covered by the patient informed consent nor approved by the participating institutional ethics committees.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
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