Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Recruiting now · Phase 1/Phase 2
Conditions studied: Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation, Positive End-expiratory Pressure (PEEP), Lung Volume, Lung Mechanics, Hemodynamic Changes, Children, ARDS, ECMO
In brief
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
Key facts
- Study ID
- NCT07193719
- Run by
- Charite University, Berlin, Germany
- People needed
- 80
- Starts
- 2025-12-05
- Expected to finish
- 2027-12-20
- Last updated by the study team
- 2026-04-09
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- ECMO study Inclusion Criteria
- patients with respiratory failure on ECMO or at risk for ECMO
- invasive ventilation
- Exclusion Criteria:
- severe lung hypoplasia or interstitial lung disease
Where it is running
- German Heart Center of the Charité — Berlin, Germany (enrolling)
Full record on ClinicalTrials.gov
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