Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Starting soon · Phase 1/Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT07486167
- Run by
- Charite University, Berlin, Germany
- People needed
- 80
- Starts
- 2026-09-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-04-30
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion Criteria
- congenital heart disease
- surgery with cardiopulmonary bypass
You may not qualify if…
- single ventricle physiology
- ECMO/VAD
- <36weeks of gestational age
- chronic lung disease
- Endotracheal tube leak > 15%
- lack of informed consent from parents.
Where it is running
- German Heart Center of the Charité — Berlin, Germany
Full record on ClinicalTrials.gov
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