Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:03 AM
Study NCT ID:
NCT07486167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Lung Volume Optimization Maneuver in Ventilated Children on Cardiac Output and Lung Compliance in Children With Congenital Heart Disease Undergoing Surgical Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statisticians'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The type of intervention is one of clinical management (ventilatory management) and does not include a specific drug or biological'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Index (L/min/BSA)', 'timeFrame': 'perioperatively', 'description': 'assessed by using POCUS'}], 'secondaryOutcomes': [{'measure': 'lung mechanics', 'timeFrame': 'perioperatively', 'description': 'lung compliance (ml/cmH2O/kg)'}, {'measure': 'right ventricular performance', 'timeFrame': 'perioperatively', 'description': 'TAPSE PAAT Strain'}, {'measure': 'ventilation distribution', 'timeFrame': 'perioperatively', 'description': 'EIT'}, {'measure': 'lung perfurision', 'timeFrame': 'perioperatively', 'description': 'EIT'}, {'measure': 'dead space fraction', 'timeFrame': 'perioperatively', 'description': 'pulmonary dead-space fraction (Vd/Vt)'}, {'measure': 'avDO2', 'timeFrame': 'perioperatively', 'description': 'difference in arteriovenous oxygen content'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiopulmonary interactions', 'end-expiratory lung volume', 'electrical impedance tomography', 'PEEP titration'], 'conditions': ['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']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass.\n\nMain hypotheses: 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/perfusion mismatch of the lung\n* need for vasopressor support?', 'detailedDescription': "The objective of the CHD study is to define the impact of a LVOM after cardiac surgery with CPB on hemodynamics and lung mechanics in children with congenital heart disease (CHD) undergoing surgery.\n\nThe Specific Aims of this work are:\n\nSpecific Aim 1:\n\nEvaluate hemodynamics and lung mechanics during and after a LVOM:\n\nIn cases of children undergoing cardiac surgery all measurements will be performed with closed chest conditions.\n\nSpecific Aim 2:\n\nEvaluate a potential benefit of lung volume optimization by performing PEEP titration on hemodynamics and lung mechanics compared to standard care without PEEP titration to optimize end-expiratory lung volume while maintaining same tidal volume targets in cases and controls.\n\nHypotheses:\n\n1. Hemodynamics and lung mechanics will be significantly different before and after LVOM. The investigators expect that there will be little difference between intervention and control group before performing PEEP titration in the interventional group.\n2. Once the PEEP titration has been performed in the interventional group, the investigators hypothesize that patients who received the intervention will have improved hemodynamics and lung mechanics with modest PEEP while receiving the same tidal volume than the control group (U-shaped curves).\n\nRationale: Surgery with cardiopulmonary bypass typically involves an interruption of mechanical ventilation while CPB is running. This is oftentimes associated with atelectasis formation and impaired gas exchange due to reduced end-expiratory lung volume. While there have been few studies in adults that have shown that optimization of lung volume by performing PEEP titration after CPB can significantly improve Cardiac Index and right ventricular function, there have been only very few prospective pediatric studies which assessed the impact of different PEEP settings on hemodynamics, and lung mechanics after cardiac surgery in children. Because these patients are generally among the most fragile postoperative patients, it is critical to understand if specific ventilator strategies can help mitigate any negative hemodynamic consequences after surgery. The purpose of this study is to understand the critical cardiopulmonary interactions that occur with changes in lung volumes, and to determine optimal approaches to mechanical ventilation under these different circumstances.\n\nCardiopulmonary interactions differ based on the underlying cardiac anatomy and physiology. Most studies of cardiopulmonary interactions following surgery for congenital heart disease have examined the difference between positive and negative pressure ventilation. This work consistently showed improvement in cardiac output and pulmonary blood flow with negative pressure ventilation, while positive pressure ventilation was associated with decreased cardiac output. However, these studies have been conducted in the 1990's and positive pressure ventilation has changed significantly in the meantime.\n\nSimilarly, while patients with left ventricular dysfunction generally benefit from positive pressure ventilation, there is little data regarding the hemodynamic effects of positive pressure ventilation on right ventricular performance.\n\nModulating pulmonary vascular resistance by optimizing lung volumes might be a promising approach to improve both lung mechanics and hemodynamics. Studies in this population have focused more on the effects of FiO2 and hyperventilation than on respiratory mechanics and cardiopulmonary interactions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': '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/VAD\n* \\<36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.'}, 'identificationModule': {'nctId': 'NCT07486167', 'acronym': 'ILOCO-CHD', 'briefTitle': 'Influence of Lung Volume Optimization Maneuver in Ventilated Children on Cardiac Output and Lung Compliance in Children With Congenital Heart Disease Undergoing Surgical Repair', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'EA 2025/06/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Procedure: Standard Care (in control arm)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '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". ECMO study: This group receives an individual lung volume optimization maneuver with PEEP titration during conventional or CDP titration with high frequency oscillatory ventilation. PEEP/CDP titration is performed while monitoring lung mechanics and EIT indices to optimize end-expiratory lung volume and find final "best PEEP/CDP".', 'interventionNames': ['Procedure: End-expiratory lung volume optimization maneuver with PEEP titration']}], 'interventions': [{'name': 'End-expiratory lung volume optimization maneuver with PEEP titration', 'type': 'PROCEDURE', 'description': "PEEP titration (incremental/decremental) 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/kg in cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate. ECMo study: PEEP/CDP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP/CDP corresponding to the best lung compliance, best match of overdistension and collapse and homogenization of tidal volume distribution (EIT).", 'armGroupLabels': ['Treatment']}, {'name': 'Standard Care (in control arm)', 'type': 'PROCEDURE', 'description': 'Patients will receive pressure controlled ventilation with target tidal volume of 6ml/kg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. No LVOM will be applied.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Center of the Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Jan C Clausen, MD', 'role': 'CONTACT', 'email': 'jan.clausen@posteo.de', 'phone': '00493045932800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jan Clausen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}