[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607835":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":89,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"control","ACTIVE_COMPARATOR","CHD study: 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\n\nECMO study: This group receives so called standard of care. This includes PEEP of 10cmH2O, peak inspiratory pressures of 20cmH2O and no standardized PEEP titration",[13],"Procedure: Standard Care (in control arm)",{"label":15,"type":16,"description":17,"interventionNames":18},"treatment","EXPERIMENTAL","CHD study: This group receives an individual lung volume optimization maneuver with PEEP titration. PEEP titration is performed while monitoring lung mechanics to optimize end-expiratory lung volume and find final \"best PEEP\".\n\nECMO study: This group receives an individual lung volume optimization maneuver with PEEP titration during conventional or CDP titration with high frequency oscillatory ventilation. PEEP\u002FCDP titration is performed while monitoring lung mechanics and EIT indices to optimize end-expiratory lung volume and find final \"best PEEP\u002FCDP\".",[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","CHD study: PEEP titration (incremental\u002Fdecremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance at the end of surgery. Typically PEEP levels between 10-20cmH2O will be applied based on individual response of patients' lung mechanics. 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.\n\nECMo study: PEEP\u002FCDP titration (incremental\u002Fdecremental) will be performed to optimize lung volume and find levels of PEEP\u002FCDP corresponding to the best lung compliance, best match of overdistension and collapse and homogenization of tidal volume distribution (EIT) .",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Care (in control arm)","CHD study: 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.\n\nECMO study: patients will receive standard ECMO ventilation (PEEP 10cmH2O and PiP 20cmH2O) without performing LVOM",[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":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"German Heart Center of the Charité","RECRUITING","Berlin","13353","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],13.41053,52.52437,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":53},"jan-christoph.clausen@charite.de",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jan Clausen","Pediatric Cardiologist\u002FIntensivist","100607835","phase-1-influence-of-personalized-lung-volume-optimization-maneuver-on-lung-function-and-cardiac-performance-in-children-100607835",false,"NCT07193719","Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children","Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children","ILOCO","CHD study:\n\nInclusion Criteria\n\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.\n\nECMO study Inclusion Criteria\n\n* patients with respiratory failure on ECMO or at risk for ECMO\n* invasive ventilation\n\nExclusion Criteria:\n\n\\- severe lung hypoplasia or interstitial lung disease","ALL","0 Years","18 Years",{"count":70,"type":71},80,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in\n\n1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and\n2. study) in children with severe respiratory failure at risk for or need for ECMO.\n\nThe main questions it aims to answer are:\n\nMain hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:\n\n* cardiac performance\n* lung function\n\nDoes it make a difference in:\n\n* length of ventilation\n* ventilation\u002Fperfusion mismatch of the lung\n* need for vasopressor support?\n\nMain hypotheses of ECMO study:\n\nDoes a LVOM in children\u002Finfants with severe respiratory failure \u002FARDS\n\n* improve lung compliance and gas exchange\n* facilitate lung protective ventilation according to PALICC-2 guidelines\n* improve lung aeration and V\u002FQ-matching assessed with EIT\n\nDoes it make a difference in\n\n* need for ECMO\n* duration of ECMO runs\n* hemodynamics stability",[78,79,80,81,82,83,84,85,86,87,88],"Congenital Heart Disease","Cardiopulmonary Bypass","Cardiac Surgery","Mechanical Ventilation","Positive End-expiratory Pressure (PEEP)","Lung Volume","Lung Mechanics","Hemodynamic Changes","Children","ARDS","ECMO",[90,91,92,87,88,93],"cardiopulmonary interactions","end-expiratory lung volume","PEEP titration","cardiopulmonary bypass","2026-04-05",{"date":96,"type":97},"2026-04-09","ACTUAL",{"date":99,"type":97},"2025-12-05",{"date":101,"type":71},"2027-12-20",{"name":5,"class":6},1]