[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529802":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":56,"collaborators":59,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":17,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":38,"whyStopped":17,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"INTELLiVENT-ASV","The ventilator set parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. The investigators monitor it and define clinical target.",[12],"Device: INTELLiVENT-ASV.",{"label":14,"type":15,"description":16,"interventionNames":17},"conventional ventilation","NO_INTERVENTION","The investigators set and monitor parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation.",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"DEVICE","INTELLiVENT-ASV.","INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs",[9],[25],{"name":26,"affiliation":5,"role":27},"Edda Tschernko, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":17,"email":32},"CONTACT","00 43 1 40400 41090","edda.tschernko@meduniwien.ac.at",{"name":34,"role":30,"phone":31,"phoneExt":17,"email":35},"Martin H. Bernardi, MD","martin.bernardi@meduniwien.ac.at",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Vienna","State of Vienna","A-1090","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],16.37208,48.20849,{"lat":48,"lon":47},[51,54,55],{"name":52,"role":30,"phone":53,"phoneExt":17,"email":35},"Martin H Bernardi, MD, PhD","004314040041090",{"name":52,"role":30,"phone":17,"phoneExt":17,"email":17},{"name":26,"role":30,"phone":17,"phoneExt":17,"email":17},{"type":27,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Prof. Dr. Edda Tschernko","Principal Investigator",[60,62,64,66],{"name":61,"class":6},"University Hospital Dubrava",{"name":63,"class":6},"Università degli Studi dell'Insubria",{"name":65,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"name":67,"class":6},"University of Zurich","100529802","i-asv-in-cardiac-surgery-100529802",false,"NCT06178510","I-ASV in Cardiac Surgery","POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial","POSITiVE II","Inclusion Criteria:\n\n* 1\\. aged \\> 18 years of age;\n* 2\\. scheduled for elective cardiac surgery; and\n* 3\\. expected to receive postoperative ventilation in the ICU for \\> 2 hours.\n\nExclusion Criteria:\n\n1. any emergency or semi-elective surgery (precluding informed written consent);\n2. any surgery other than CABG, valve replacement or repair, or a combination (i.e., patients planned for surgery for congenital heart disease, or scheduled for heart transplantation are excluded);\n3. enrolled in another interventional trail;\n4. no written informed consent obtained;\n5. history of recent pneumectomy or lobectomy;\n6. history of COPD with oxygen at home;\n7. body mass index \\> 35;\n8. preoperative forced expiratory volume in the first second (FeV1)\u002Fforced vital capacity (VC) \\\u003C 50% (if available);\n9. preoperative arterial oxygen partial pressure (PaO2) \\\u003C 60 mm Hg (at room air);\n10. preoperative arterial carbon dioxide partial pressure (PaCO2) \\> 50 mm Hg;\n11. preoperative left ventricular ejection fraction \\\u003C 30% (if available);\n12. preoperative systolic pulmonary artery pressure \\> 60 mm Hg (if available);\n13. preoperative left ventricular mechanical support, e.g., Impella®; or\n14. preoperative use of veno-venous or veno-arterial extracorporeal support\n\n    At the end of surgery, patients are additionally excluded if a patient:\n15. cannot be weaned from the extracorporeal support; or\n16. unexpectedly needs implementation of an assist device","ALL","18 Years","120 Years",{"count":80,"type":81},328,"ESTIMATED","INTERVENTIONAL",[84],"NA","'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.",[87],"Ventilator Lung",[89,90,91,92],"Adaptative Support Ventilation","INTELLiVENT","Cardiac Surgery","Workload","2024-10-31",{"date":95,"type":96},"2024-11-04","ACTUAL",{"date":98,"type":96},"2024-05-31",{"date":100,"type":81},"2025-12",{"name":5,"class":6},1]