[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653238":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":49,"studyPopulation":46,"armGroups":50,"interventions":63,"overallOfficials":77,"centralContacts":82,"locations":91,"responsibleParty":123,"collaborators":46,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":46,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":46,"enrollmentInfo":135,"targetDuration":46,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":149,"whyStopped":46,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Hospital del Mar Research Institute (IMIM)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Respiratory Rate From Baseline to 4 Hours","Change in respiratory rate, measured in breaths per minute, from the study baseline to 4 hours after initiation of ECCO2R in the experimental arm or the corresponding study time point in the control arm. A negative value indicates a reduction in respiratory rate.","Baseline and 4 hours after initiation of the assigned treatment",[14,17,20,24,28,32],{"measure":15,"description":16,"timeFrame":12},"Change in Arterial Carbon Dioxide Pressure","Change in arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg, from baseline to 4 hours after initiation of the assigned treatment.",{"measure":18,"description":19,"timeFrame":12},"Change in Arterial pH","Change in arterial blood pH from baseline to 4 hours after initiation of the assigned treatment.",{"measure":21,"description":22,"timeFrame":23},"Duration of Noninvasive Ventilation","Total duration of noninvasive ventilation, measured in hours, from initiation until permanent discontinuation during the index hospitalization.","From initiation of noninvasive ventilation until its permanent discontinuation, assessed through hospital discharge or death",{"measure":25,"description":26,"timeFrame":27},"Hospital Length of Stay","Number of days from hospital admission to hospital discharge or in-hospital death.","From hospital admission through hospital discharge or death, anticipated up to 90 days",{"measure":29,"description":30,"timeFrame":31},"In-Hospital Mortality","All-cause mortality occurring during the index hospitalization.","From randomization through hospital discharge, anticipated up to 90 days",{"measure":33,"description":34,"timeFrame":35},"Incidence of ECCO2R-Related Adverse Events","Number and proportion of participants experiencing one or more adverse events considered related to ECCO2R, including bleeding, thrombocytopenia, vascular catheter complications, hemolysis, circuit clotting, air entry, reduced blood flow, or other mechanical system failures.","From initiation of ECCO2R through hospital discharge or death, anticipated up to 90 days",[37],{"measure":38,"description":39,"timeFrame":40},"Intensive Care Unit Length of Stay","Number of days from intensive care unit admission to intensive care unit discharge or death in the intensive care unit.","From intensive care unit admission through intensive care unit discharge or death, anticipated up to 90 days",{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":46,"timePerspective":46,"maskingInfo":47},"RANDOMIZED","PARALLEL","Participants are randomly assigned in a 1:1 ratio to receive either noninvasive ventilation plus extracorporeal carbon dioxide removal or noninvasive ventilation alone.","TREATMENT",null,{"masking":48,"maskingDescription":46,"whoMasked":46},"NONE","Acute exacerbations of chronic obstructive pulmonary disease (COPD) may cause severe hypercapnic respiratory failure. Noninvasive ventilation (NIV) is the standard initial respiratory support, but some patients have persistent respiratory acidosis despite NIV. Treatment options are particularly limited when invasive mechanical ventilation is not considered appropriate or is declined by the patient.\n\nExtracorporeal carbon dioxide removal (ECCO2R) uses a low-flow extracorporeal circuit to remove carbon dioxide directly from the blood. When used together with NIV, ECCO2R may reduce the ventilatory demand and work of breathing, improve respiratory acidosis, and facilitate earlier withdrawal of NIV.\n\nThis single-center, open-label, randomized proof-of-concept trial will compare NIV plus ECCO2R with NIV alone in patients with an acute exacerbation of COPD and persistent hypercapnic respiratory acidosis after 4 hours of NIV. The study is intended to provide preliminary evidence regarding the physiological effects, clinical feasibility, and safety of adding ECCO2R to standard NIV in this highly selected population. The findings may inform the design of larger clinical trials.",[51,58],{"label":52,"type":53,"description":54,"interventionNames":55},"NIV Plus ECCO2R","EXPERIMENTAL","Participants receive standard noninvasive ventilation together with extracorporeal carbon dioxide removal.",[56,57],"Device: Extracorporeal Carbon Dioxide Removal","Device: Noninvasive Ventilation",{"label":59,"type":60,"description":61,"interventionNames":62},"NIV Alone","ACTIVE_COMPARATOR","Participants continue to receive standard noninvasive ventilation alone according to current clinical guidelines and usual clinical practice.",[57],[64,71],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DEVICE","Extracorporeal Carbon Dioxide Removal","Low-flow extracorporeal carbon dioxide removal will be provided using the Prismalung+ membrane connected to the PrisMax 2 system. Treatment will be initiated within 12 hours after randomization through a 13- to 14-Fr double-lumen venous catheter. The initial sweep gas flow will be 10 L\u002Fmin, and blood flow will be set as high as tolerated by the system, with a target of approximately 450 mL\u002Fmin. Treatment settings will be adjusted according to carbon dioxide removal and arterial pH.",[52],[70],"ECCO2R",{"type":65,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Noninvasive Ventilation","Noninvasive ventilation will be delivered according to current clinical guidelines and usual clinical practice. Ventilator settings and duration of treatment will be adjusted by the treating clinical team according to the participant's respiratory status and clinical response.",[59,52],[76],"NIV",[78],{"name":79,"affiliation":80,"role":81},"Francisco José Parrilla Gómez, MD, PhD","Hospital del Mar","PRINCIPAL_INVESTIGATOR",[83,87],{"name":79,"role":84,"phone":85,"phoneExt":46,"email":86},"CONTACT","+34 93 248 30 14","fparrilla@hmar.cat",{"name":88,"role":84,"phone":89,"phoneExt":46,"email":90},"Andrea Castellvi-Font, MD, PhD","+34 636568294","acastellvifont@hmar.cat",[92],{"facility":80,"status":46,"city":93,"state":46,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Barcelona","08023","Spain","ES",{"type":98,"coordinates":99},"Point",[100,101],2.15899,41.38879,{"lat":101,"lon":100},[104,105,108,111,112,113,115,117,119,121],{"name":79,"role":84,"phone":85,"phoneExt":46,"email":86},{"name":106,"role":84,"phone":85,"phoneExt":46,"email":107},"Joan Ramon Masclans Enviz, MD, PhD","jmasclans@hmar.cat",{"name":109,"role":110,"phone":46,"phoneExt":46,"email":46},"Andrea Castellví-Font, MD, PhD","SUB_INVESTIGATOR",{"name":79,"role":81,"phone":46,"phoneExt":46,"email":46},{"name":106,"role":110,"phone":46,"phoneExt":46,"email":46},{"name":114,"role":110,"phone":46,"phoneExt":46,"email":46},"Purificación Pérez Terán, MD, PhD",{"name":116,"role":110,"phone":46,"phoneExt":46,"email":46},"Maria Acer Puig, MD",{"name":118,"role":110,"phone":46,"phoneExt":46,"email":46},"Rosana Muñoz Bermúdez, MD",{"name":120,"role":110,"phone":46,"phoneExt":46,"email":46},"Clara Vilà Vilardell, MD",{"name":122,"role":110,"phone":46,"phoneExt":46,"email":46},"Laia Ribó, MD",{"type":81,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Andrea Castellvi","Staff Intensivist and Clinical Researcher, Department of Intensive Care Medicine","100653238","extracorporeal-carbon-dioxide-removal-plus-noninvasive-ventilation-in-patients-with-copd-not-eligible-for-intubation-100653238",false,"NCT07785375","Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation","Randomized Clinical Trial of the Efficacy of Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation in Patients With COPD Not Eligible for Endotracheal Intubation","Inclusion Criteria:\n\n* Age 18 years or older.\n* Confirmed diagnosis of chronic obstructive pulmonary disease (COPD).\n* Acute exacerbation of COPD, defined as increased dyspnea, cough, and\u002For sputum production.\n* Acute hypercapnic respiratory failure requiring noninvasive ventilation, with arterial pH \\\u003C7.30 and PaCO2 \\>50 mmHg.\n* Not eligible for endotracheal intubation because of a medical decision or the participant's prior decision.\n* Persistent respiratory acidosis, defined as arterial pH \\\u003C7.30 with PaCO2 \\>45 mmHg, after 4 hours of noninvasive ventilation.\n\nExclusion Criteria:\n\n* Contraindication to extracorporeal carbon dioxide removal due to a coagulation disorder.\n* Inability to establish adequate vascular access.","ALL","18 Years",{"count":136,"type":137},14,"ESTIMATED","INTERVENTIONAL",[140],"NA","This study will evaluate whether adding extracorporeal carbon dioxide removal (ECCO2R) to noninvasive ventilation can improve breathing in adults hospitalized with a severe worsening of chronic obstructive pulmonary disease (COPD). Participants will have high carbon dioxide levels and increased acidity in their blood despite treatment with noninvasive ventilation and will not be eligible for invasive mechanical ventilation through a breathing tube.\n\nA total of 14 participants will be assigned by chance to receive either noninvasive ventilation alone or noninvasive ventilation together with ECCO2R. ECCO2R removes carbon dioxide directly from the blood through a catheter placed in a large vein. The main aim is to determine whether adding ECCO2R reduces the breathing rate within 4 hours. The study will also assess blood carbon dioxide and acidity, duration of noninvasive ventilation, length of hospital stay, survival, and complications related to ECCO2R.",[143],"Acute Exacerbation of Chronic Obstructive Pulmonary Disease",[66,70,72,76,145,146,147,148],"Acute Hypercapnic Respiratory Failure","Respiratory Acidosis","COPD Exacerbation","Do-Not-Intubate Order","NOT_YET_RECRUITING","2026-08-21",{"date":152,"type":153},"2026-08-25","ACTUAL",{"date":155,"type":137},"2026-09",{"date":157,"type":137},"2028-03",{"name":5,"class":6},1]