NCT07193719View on ClinicalTrials.gov

Influence of Lung Volume Optimization After Cardiopulmonary Bypass on Cardiac Output and Lung Compliance in Children Undergoing Biventricular Repair of Their Congenital Heart Disease

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 5, 2026

Primary Completion Date

May 31, 2027

Study Completion Date

December 20, 2027

Conditions
Congenital Heart DiseaseCardiopulmonary BypassCardiac SurgeryMechanical VentilationPositive End-expiratory Pressure (PEEP)Lung VolumeLung MechanicsHemodynamic ChangesChildren
Interventions
PROCEDURE

End-expiratory lung volume optimization maneuver with PEEP titration

PEEP titration (incremental/decremental) will be performed to optimize lung volume after surgery and find levels of PEEP corresponding to the best lung compliance. 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 both arms. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate.

PROCEDURE

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.

Trial Locations (1)

13353

German Heart Center of the Charité, Berlin

All Listed Sponsors
lead

Charite University, Berlin, Germany

OTHER

NCT07193719 - Influence of Lung Volume Optimization After Cardiopulmonary Bypass on Cardiac Output and Lung Compliance in Children Undergoing Biventricular Repair of Their Congenital Heart Disease | Biotech Hunter | Biotech Hunter