Status:
NOT_YET_RECRUITING
Influence of Lung Volume Optimization After Cardiopulmonary Bypass on Cardiac Output and Lung Compliance in Children Undergoing Biventricular Repair of Their Congenital Heart Disease
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Congenital Heart Disease
Cardiopulmonary Bypass
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver after cardiac surgery with cardiopulmonary bypass (CPB) is beneficial in child...
Detailed Description
The objective of this study is to define the impact of variable levels of PEEP and on hemodynamics and lung mechanics in children undergoing biventricular repair of their congenital heart disease (CHD...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- congenital heart disease
- surgery with cardiopulmonary bypass
- Exclusion Criteria:
- single ventricle physiology
- ECMO/VAD
- \<36weeks of gestational age
- chronic lung disease
- Endotracheal tube leak \> 15%
- lack of informed consent from parents.
Exclusion
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07193719
Start Date
January 5 2026
End Date
December 20 2027
Last Update
October 1 2025
Active Locations (1)
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1
German Heart Center of the Charité
Berlin, Germany, 13353