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

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.

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