[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630322":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":49,"collaborators":26,"id":53,"slug":26,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":82,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","This group receives so called standard of care. This includes relatively low levels of PEEP (5cmH2O in case of planned surgery) and no standardized PEEP titration.",[13],"Procedure: Standard Care (in control arm)",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment","EXPERIMENTAL","This group receives an individual lung volume optimization maneuver with PEEP titration. PEEP titration is performed while monitoring lung mechanics and EIT indices of overdistension and collapse and regional tidal volume distribution to optimize end-expiratory lung volume and find final \"best PEEP\". If possible lung perfusion will be assessed with EIT to evaluate V\u002FQ-matching.",[19],"Procedure: End-expiratory lung volume optimization maneuver with PEEP titration",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","End-expiratory lung volume optimization maneuver with PEEP titration","PEEP titration (incremental\u002Fdecremental) will be performed at the end of surgery to optimize lung volume and find levels of PEEP corresponding to the \"best\" lung compliance and \"best\" compromise of overdistension and collapse and \"best\" homogenization of tidal volume distribution assessed with EIT. PEEP levels will be applied based on individual response of patients' lung mechanics and EIT measures. Tidal volume will be kept constant at 6ml\u002Fkg in cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Care (in control arm)","Patients will receive pressure controlled ventilation with target tidal volume of 6ml\u002Fkg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. No LVOM will be applied.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jan C Clausen, MD","CONTACT","00493045932800","jan.clausen@posteo.de",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"German Heart Center of the Charité","Berlin","13353","Germany",{"type":44,"coordinates":45},"Point",[46,47],13.41053,52.52437,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jan Clausen","Principal Investigator","100630322",false,"NCT07486167","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease","ILOCO-CHD","Inclusion Criteria:\n\n* Inclusion Criteria\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.","ALL","0 Days","18 Years",{"count":64,"type":65},80,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE1","PHASE2","The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.\n\nThe primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.\n\nSecondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.",[72,73,74,75,76,77,78,79,80,81],"Congenital Heart Disease","Cardiopulmonary Bypass","Mechanical Ventilation","Peep Titration in Lung Protective Ventilation","Positive End-expiratory Pressure (PEEP)","Lung Volume","Lung Mechanics","Children","Hemodynamic Changes","Cardiac Surgery",[83,84,85,86],"cardiopulmonary interactions","end-expiratory lung volume","electrical impedance tomography","PEEP titration","NOT_YET_RECRUITING","2026-04-26",{"date":90,"type":91},"2026-04-30","ACTUAL",{"date":93,"type":65},"2026-09-01",{"date":95,"type":65},"2028-12-31",{"name":5,"class":6},1]