[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431834":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":47,"responsibleParty":64,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":26,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Bologna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ECCO2R","EXPERIMENTAL","Patients will be initially treated with \"standardized ventilation\": volume assist\u002Fcontrol, VT = 6 mL\u002Fkg PBW; insp. flow 50-70 L\u002Fmin, I:E ratio 1:1 to 1:3; RR 20-35 bpm; PEEP according to \"low PEEP\u002F high FiO2\" table. Goals: PaO2 55-80 mmHg or SpO2 88-95%; arterial pH: 7.30-7.45.\n\nECCO2R initiated during \"standardized ventilation\" with blood flow between 1000 and 1500 mL\u002Fmin. Anticoagulation with unfractionated heparin to a target aPTT of 1.5-2.0x baseline. Target: maintain PaCO2 at baseline ± 20%.\n\nVT initially reduced to 5 mL\u002Fkg. Sweep gas initiated and VT decreased to 4.5 then 4 mL\u002Fkg; PEEP adjusted to maintain same mean airway pressure as during \"standardized ventilation\", provided that Pplat ≤ 25 cmH2O.\n\nRespiratory rate decreased to 8 bpm. If PaCO2 \\> 75 mmHg and\u002For pH \\\u003C 7.2, despite respiratory rate of 35\u002Fmin and optimized ECCO2R, VT will be increased to the last previously tolerated VT.\n\nRecommendation: 2 daily lung recruitment maneuvers (as per clinical practice in each center).",[13],"Procedure: Ultraprotective ventilation with Extracorporeal CO2 removal",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","ACTIVE_COMPARATOR","Patients will be treated with \"standardized ventilation\": volume assist\u002Fcontrol, VT = 6 mL\u002Fkg PBW; insp. flow 50-70 L\u002Fmin, I:E ratio 1:1 to 1:3; RR 20-35 bpm; PEEP according to \"low PEEP\u002F high FiO2\" table. Goals: PaO2 55-80 mmHg or SpO2 88-95%; arterial pH: 7.30-7.45.\n\nRecommendation: 2 daily lung recruitment maneuvers (as per clinical practice in each center).",[19],"Procedure: Conventional protective ventilation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Ultraprotective ventilation with Extracorporeal CO2 removal","HLS5.0 Cardiohelp® (Getinge Cardiopulmonary Care, Rastatt, Germany): 1.3 m² polymethylpentene hollow fiber membrane oxygenator. The extracorporeal blood flow is in the range of 1000 to 1500 mL\u002Fmin. Sweep gas (air or oxygen) is drawn through the hollow fibers by a vacuum pump, creating a diffusion gradient for gas exchange across the membrane.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional protective ventilation","Conventional lung protective mechanical ventilation, as described in the arm description (\"standardized ventilation\")",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Marco Ranieri, M.D.","University of Bari","STUDY_CHAIR",{"name":37,"affiliation":38,"role":35},"Antonio Pesenti, M.D.","University of Milan",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Tommaso Tonetti, M.D.","CONTACT","+39-0512143268","tommaso.tonetti@unibo.it",{"name":33,"role":42,"phone":43,"phoneExt":26,"email":46},"m.ranieri@unibo.it",[48],{"facility":49,"status":50,"city":51,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"IRCCS AOUBO Policlinico di Sant'Orsola","RECRUITING","Bologna","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],11.33875,44.49381,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":63,"phoneExt":26,"email":44},"Tommaso Tonetti","+390512143268",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":68,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","V. Marco Ranieri","Full Professor","University of Bari Aldo Moro",[70],{"name":71,"class":6},"Getinge Group","100431834","ultra-protective-lung-ventilation-with-extracorporeal-co2-removal-for-moderate-ards-100431834",false,"NCT04903262","Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS","Strategy of Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for New-Onset Moderate ARDS: A Prospective Multicenter Randomized Clinical Trial","SUPERNOVA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* On invasive mechanical ventilation for ≤ 96 hours\n* Presence of all of the following conditions for ≤ 24 hours: 100 \\\u003C PaO2\u002FFiO2 ≤ 200 after 12 hours of \"standardized ventilation\" with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml\u002FcmH2O per kg PBW; ventilatory ratio (VR) ≥ 1.5; bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules; respiratory failure not fully explained by cardiac failure or fluid overload\n\nExclusion Criteria:\n\n* Pregnancy\n* ARDS with PaO2\u002FFiO2\\\u003C100 or PaO2\u002FFiO2\\>200 under standardized ventilation with PEEP ≥ 5 cmH2O\n* Expected duration of mechanical ventilation \\\u003C 48 hours\n* Severe COPD\n* Chronic respiratory insufficiency with home ventilation or oxygen therapy\n* Currently receiving ECMO therapy\n* Acute brain injury\n* Severe liver insufficiency (Child-Pugh scores \\>7) or fulminant hepatic failure\n* Heparin-induced thrombocytopenia\n* Contraindication for systemic anticoagulation\n* Platelet count \\\u003C50,000\u002Fmm3\n* Prothrombin time-international normalized ratio (INR) \\>1.5\n* Patient moribund, decision to limit therapeutic interventions\n* End-stage disease\n* Unable to provide vascular access for ECCO2-R\n* Acute coronary syndrome\n* Actual body weight exceeding 1 kg per centimeter of height\n* Burns \\> 40% total body surface\n* Bone marrow transplantation within the last 1 year","ALL","18 Years","100 Years",{"count":84,"type":85},230,"ESTIMATED","INTERVENTIONAL",[88],"NA","Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings.\n\nThe main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.",[91],"Acute Respiratory Distress Syndrome","2025-03-27",{"date":94,"type":95},"2025-04-02","ACTUAL",{"date":97,"type":95},"2024-12-01",{"date":99,"type":85},"2027-03-31",{"name":5,"class":6},1]