[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658883":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":53,"overallOfficials":37,"centralContacts":37,"locations":67,"responsibleParty":101,"collaborators":37,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":37,"enrollmentInfo":114,"targetDuration":37,"studyType":117,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":127,"whyStopped":37,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Chulalongkorn University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage Change in PaCO₂ From Baseline","Percentage change in arterial partial pressure of carbon dioxide (PaCO₂) from baseline after initiation of ultra-low-flow ECCO₂R.\n\nUnit of Measure: Percent (%)","Baseline and 1, 6, 12, 24, 48, and 72 hours after initiation of ECCO₂R.",[14,18,22,26,30,34],{"measure":15,"description":16,"timeFrame":17},"Percentage of Participants Achieving Correction of Hypercapnic Respiratory Acidosis","Percentage of achievement (% of achievement) in resolving hypercapnic respiratory acidosis (PaCO2 \\\u003C 50 mmHg and pH\\>7.30) from hour 0 in acute respiratory distress syndrome (ARDS) patients ventilated using a lung protective strategy with ECCO2R, evaluated for each catheter size at 1, 6, 12, 24, 48, and 72 hours.","1, 6, 12, 24, 48, and 72 hours after using a lung protective strategy under ECCO2R",{"measure":19,"description":20,"timeFrame":21},"Time to achievement (hours) in resolving hypercapnic respiratory acidosis","Time to achievement (hours) in resolving hypercapnic respiratory acidosis from hour 0 in acute respiratory distress syndrome (ARDS) patients ventilated using a lung protective strategy with ECCO2R, evaluated for each catheter size.","From using a lung protective strategy under ECCO₂R through 72 hours.",{"measure":23,"description":24,"timeFrame":25},"Change in PaO₂\u002FFiO2 ratio From Baseline","Change in PaO₂\u002FFiO2 ratio from baseline following initiation of ECCO₂R.","1, 6, 12, 24, 48, and 72 hours.",{"measure":27,"description":28,"timeFrame":29},"Circuit Lifespan","Duration of use of the ECCO₂R circuit from initiation until circuit replacement or discontinuation.","From initiation of ECCO₂R through 72 hours.",{"measure":31,"description":32,"timeFrame":33},"Maximum Blood Flow Achieved During ECCO₂R","Maximum blood flow rate achieved during ECCO₂R while maintaining MAP \\>65 mmHg and protocol-defined circuit pressure safety criteria.","During the ECCO₂R treatment period, up to 72 hours.",{"measure":35,"description":36,"timeFrame":29},"ECCO₂R-Related Complications","Occurrence of complications including catheter-related bleeding, anemia requring blood transfusion, hemolysis, catheter infection, circuit thrombosis, hemodynamic instability, and other patient- or device-related complications.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","Acute respiratory distress syndrome (ARDS) may require lung-protective mechanical ventilation to reduce ventilator-induced lung injury. However, limiting tidal volume, driving pressure, plateau pressure, respiratory rate, and mechanical power may result in hypercapnia and respiratory acidosis in some patients.\n\nUltra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) may facilitate carbon dioxide removal while allowing maintenance of a lung-protective or ultra-protective ventilatory strategy. Compared with conventional high-flow extracorporeal carbon dioxide removal, ultra-low-flow ECCO₂R can be performed using smaller vascular catheters.\n\nThe efficacy of ultra-low-flow ECCO₂R may be influenced by catheter size because catheter diameter affects vascular resistance and achievable blood flow through the extracorporeal circuit. However, the optimal catheter size for achieving effective carbon dioxide removal while minimizing catheter-related risks remains uncertain.\n\nThis study is a prospective, randomized, three-arm pilot study. Adult patients with ARDS and hypercapnic respiratory acidosis who meet predefined criteria despite lung-protective mechanical ventilation will be randomly assigned to receive ultra-low-flow ECCO₂R using a 12F, 13F, or 15F catheter.\n\nParticipants will undergo ECCO₂R for a minimum of 72 hours or until predefined criteria for discontinuation are met. Blood flow will initially be set within the protocol-defined range and increased incrementally according to PaCO₂ response and hemodynamic safety parameters.\n\nThe study will evaluate the effect of catheter size on carbon dioxide removal, correction of hypercapnic respiratory acidosis, oxygenation, circuit lifespan, maximum blood flow, and patient- and device-related complications.",[46],{"label":47,"type":48,"description":37,"interventionNames":49},"Ultralow-flow extracorporeal carbon dioxide removal system","EXPERIMENTAL",[50,51,52],"Device: 12F Catheter","Device: 13F Catheter","Device: 15F Catheter",[54,59,63],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":37},"DEVICE","12F Catheter","Participants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 12 French (12F) catheter",[47],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":37},"13F Catheter","Participants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 13 French (13F) catheter",[47],{"type":55,"name":64,"description":65,"armGroupLabels":66,"otherNames":37},"15F Catheter","Participants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 15 French (15F) catheter",[47],[68],{"facility":69,"status":37,"city":70,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Chulalongkorn university","Bangkok","10330","Thailand","TH",{"type":75,"coordinates":76},"Point",[77,78],100.50144,13.75398,{"lat":78,"lon":77},[81,86,90,93,95,97,99],{"name":82,"role":83,"phone":84,"phoneExt":37,"email":85},"Nattachai Srisawat, Prof. Dr.","CONTACT","02 256 4000 Ext. 3597, 3678","drnattachai@yahoo.com",{"name":87,"role":83,"phone":88,"phoneExt":37,"email":89},"Phruet Soipetkasem, MD","0612708090","phruetsoi@gmail.com",{"name":91,"role":92,"phone":37,"phoneExt":37,"email":37},"Nattachai Srisawat, MD, PhD, Professor","PRINCIPAL_INVESTIGATOR",{"name":87,"role":94,"phone":37,"phoneExt":37,"email":37},"SUB_INVESTIGATOR",{"name":96,"role":94,"phone":37,"phoneExt":37,"email":37},"Nattha Lumlertgul, MD, PhD",{"name":98,"role":94,"phone":37,"phoneExt":37,"email":37},"Sadudee Peerapornratana, MD",{"name":100,"role":94,"phone":37,"phoneExt":37,"email":37},"Pongthep Theerawit, MD, Assoc. Prof.",{"type":92,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Nattachai Srisawat ,M.D.","Principal investigator","100658883","the-effect-of-catheter-size-on-the-efficacy-of-ultralow-flow-extracorporeal-carbon-dioxide-removal-system-in-acute-respiratory-distress-syndrome-100658883",false,"NCT07858136","The Effect of Catheter Size on the Efficacy of Ultralow-flow Extracorporeal Carbon Dioxide Removal System in Acute Respiratory Distress Syndrome","The Effect of Catheter Size on the Efficacy of Ultralow-flow Extracorporeal Carbon Dioxide Removal System in Acute Respiratory Distress Syndrome: a Pilot Randomized Controlled Trial","Cath-COR","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 years.\n2. Acute respiratory distress syndrome (ARDS), mild to moderate severity, with a PaO₂\u002FFiO₂ ratio of 100-300 while receiving PEEP ≥5 cmH₂O, after initiation of mechanical ventilation within the preceding 72 hours.\n3. Hypercapnic respiratory acidosis, defined by PaCO₂ \\>60 mmHg and\u002For arterial blood gas pH \\\u003C7.25 due to respiratory acidosis despite mechanical ventilation exceeding the protocol-defined lung-protective strategy, characterized by one or more of the following:\n\n   * Driving pressure \\>15 cmH₂O;\n   * Plateau pressure \\>27 cmH₂O;\n   * Tidal volume \\>6 mL\u002Fkg predicted body weight; or\n   * Mechanical power \\>17 J\u002Fmin associated with respiratory rate \\>25 breaths\u002Fmin.\n\nExclusion Criteria:\n\n* Severe shock that is preload non-responsive and requires norepinephrine \\>1 µg\u002Fkg\u002Fmin.\n* Acute brain injury or cerebral edema, increased intracranial pressure, status epilepticus, intracerebral hemorrhage, or acute ischemic stroke.\n* Pregnancy.\n* Morbid obesity with BMI \\>40 kg\u002Fm².\n* Chronic respiratory acidosis.\n* End-stage cancer patients.\n* Coagulation disorders, defined as a platelet count of less than 10,000 cells\u002Fmm3 or an INR greater than 3.\n* Patients undergoing targeted temperature management for 24 hours after return of spontaneous circulation.\n* End-stage renal disease (ESRD) patients with a blood urea nitrogen (BUN) level greater than 60 mg\u002FdL.\n* Patients or legal representatives who do not consent to participation.\n* Patients with an indication for ECMO according to the EOLIA trial criteria, specifically a PF ratio \\\u003C 50 mmHg more than 3 hours or a PF ratio \\\u003C 80 mmHg more than 6 hours.","ALL","18 Years",{"count":115,"type":116},30,"ESTIMATED","INTERVENTIONAL",[39],"This pilot randomized controlled trial will evaluate whether catheter size affects the efficacy and performance of ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) and hypercapnic respiratory acidosis. Participants will be randomly assigned to receive ECCO₂R using a 12F, 13F, or 15F catheter. The primary outcome is the percentage change in PaCO₂ from baseline during ECCO₂R. Secondary outcomes include achievement and time to correction of hypercapnic respiratory acidosis, changes in PaO₂, circuit lifespan, maximum blood flow, and device- and patient-related complications.",[121],"ARDS (Acute Respiratory Distress Syndrome)",[123,124,125,126],"ARDS","ECCO2R","lung protective ventilator","lung mechanics","NOT_YET_RECRUITING","2026-10-05",{"date":130,"type":131},"2026-10-08","ACTUAL",{"date":133,"type":116},"2026-12-01",{"date":135,"type":116},"2029-12-30",{"name":5,"class":6},1]