Clinical Research Directory
Browse clinical research sites, groups, and studies.
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Sponsor: Charite University, Berlin, Germany
Summary
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.
Official title: Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease
Key Details
Gender
All
Age Range
0 Days - 18 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-09-01
Completion Date
2028-12-31
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
End-expiratory lung volume optimization maneuver with PEEP titration
PEEP titration (incremental/decremental) 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/kg in cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate.
Standard Care (in control arm)
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.
Locations (1)
German Heart Center of the Charité
Berlin, Germany