Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and 2. study) in children with severe respiratory failure at risk for or need for ECMO. The main questions it aims to answer are: Main hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve: * cardiac performance * lung function Does it make a difference in: * length of ventilation * ventilation/perfusion mismatch of the lung * need for vasopressor support? Main hypotheses of ECMO study: Does a LVOM in children/infants with severe respiratory failure /ARDS * improve lung compliance and gas exchange * facilitate lung protective ventilation according to PALICC-2 guidelines * improve lung aeration and V/Q-matching assessed with EIT Does it make a difference in * need for ECMO * duration of ECMO runs * hemodynamics stability

NCT Number	NCT07193719
Lead Sponsor	Charite University, Berlin, Germany
Conditions	Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes +3 more
Enrollment	80 participants
Start Date	2025-12-05
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-12-20 (estimated)
Updated on ClinicalTrials.gov	2026-04-09