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Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair

Study acronym: ILOCO-CHD
StatusNot Yet Recruiting
PhasePhase 1/2
Started2026-09-01
View on ClinicalTrials.gov ↗

Amendment history

2026-04-26
Study Status, Study Description v5
Study description-621 characters
Brief Summary This randomized interventional trial evaluates whether a standardized lung volume optimization maneuver (LVOM), including individualized PEEP titration, improves cardiopulmonary function in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary [...] Cardiopulmonary bypass is associated with interruption of ve [...] ulation, optimizing lung volume may reduce RV afterload and enhanceimprove overall cardiac performance. Importantly, pulmonary vascula [...]
2026-04-22
Study Status, Study Description, Arms and Interventions, References v4
Study description-611 characters
TheBrief objectiveSummary ofThis therandomized CHDinterventional studytrial isevaluates to define the impact ofwhether a LVOM after cardiac surgery with CPB on hemodynamics andstandardized lung mechanicsvolume optimization maneuver (LVOM), including individualized PEEP titration, improves cardiopulmonary function in children withundergoing biventricular repair for congenital heart disease (CHD) undergoingwith surgerycardiopulmonary bypass (CPB). The primary objective is to determine whether optimization of end-expiratory lung volume improves cardiac performance and lung function. Secondary obj [...] [...]
2026-04-16
Study Status, Arms and Interventions v3
Re-verified, no change to tracked fields
2026-04-10
Study Identification, Study Status v2
Study title-12 characters
Influence of Lung Volume Optimization Maneuver in Ventilated Children on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
2026-03-21
Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions v1
Study description+30 characters
[...] nics will be significantly different before and after LVOM. WeThe investigators expect that there will be little difference between interve [...] P titration has been performed in the interventional group, wethe investigators hypothesize that patients who received the intervention wil [...]
2026-03-17
Original filing
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. The primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function. Secondary 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.
Trial Details
NCT Number NCT07486167
Lead Sponsor Charite University, Berlin, Germany
Conditions Congenital Heart Disease, Cardiopulmonary Bypass, Mechanical Ventilation, Peep Titration in Lung Protective Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Children +2 more
Enrollment 80 participants
Start Date 2026-09-01
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-30