[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645172":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Air Liquide Healthcare Spain","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NIV+TM Cohort",null,"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.",[13],"Device: Home Non-Invasive Ventilation and Telemonitoring",{"label":15,"type":10,"description":16,"interventionNames":10},"Conventional NIV Cohort","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).",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DEVICE","Home Non-Invasive Ventilation and Telemonitoring","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.",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Daniel López Padilla, MD, PhD","CONTACT","91 586 83 28","danieleduardo.lopez@salud.madrid.org",[30],{"facility":31,"status":10,"city":32,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Hospital General Universitario Gregorio Marañón","Madrid","28007","Spain","ES",{"type":37,"coordinates":38},"Point",[39,40],-3.70256,40.4165,{"lat":40,"lon":39},[43],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100645172","effectiveness-and-efficiency-of-home-telemonitoring-and-non-invasive-ventilation-in-patients-with-copd-and-hypercapnia-evaleco-100645172",false,"NCT07679646","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","EVALECO","Inclusion Criteria:\n\n1. Age between 50 and 90 years.\n2. 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) \\\u003C 50% of the predicted value confirmed by spirometry.\n3. Persistent hypercapnia, defined as PaCO2 \\> 53 mmHg documented for at least two weeks following an acute COPD exacerbation.\n4. History of two or more acute COPD exacerbations within the preceding year.\n5. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Prior ongoing treatment with home non-invasive ventilation (NIV) or Continuous Positive Airway Pressure (CPAP).\n2. Severe obstructive sleep apnea (OSA), defined as an Apnea-Hypopnea Index (AHI) \\>= 30.\n3. Inability of the patient or the primary caregiver to comprehend or operate the telemonitoring and NIV procedures.\n4. Estimated life expectancy of less than one year.\n5. Terminal heart failure (New York Heart Association \\[NYHA\\] Class III-IV) or unstable angina.\n6. Advanced renal insufficiency (creatinine clearance \\\u003C 30%) or inclusion in an active dialysis program.\n7. Hepatic cirrhosis or active inclusion in a liver transplant program.\n8. Severe psychiatric illness requiring antipsychotic medication, active ongoing treatment for substance or alcohol addiction, or lack of a fixed home address upon hospital discharge.\n9. Receipt of home palliative care.\n10. Institutionalization.\n11. Classification by the attending physician as non-compliant with medical therapies, treatments, or study protocols","ALL","50 Years","90 Years",{"count":58,"type":59},92,"ESTIMATED","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:\n\n1. One group of patients will receive standard home non-invasive ventilation alone.\n2. 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.",[63,64],"Pulmonary Disease, Chronic Obstructive (COPD)","Hypercapnia",[66,67,68],"Home Noninvasive Ventilation","Telemonitoring","Respiratory Insufficiency","NOT_YET_RECRUITING","2026-06-29",{"date":72,"type":73},"2026-07-01","ACTUAL",{"date":75,"type":59},"2026-07",{"date":77,"type":59},"2026-12",{"name":5,"class":6},1]