Actively Recruiting
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Led by Charite University, Berlin, Germany · Updated on 2026-04-09
80
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with congenital heart disease undergoing surgery with cardiopulmonary bypass
- Patients with respiratory failure on ECMO or at risk for ECMO and receiving invasive ventilation
You will not qualify if you...
- Single ventricle physiology
- Use of ECMO or ventricular assist device
- Gestational age less than 36 weeks
- Chronic lung disease
- Endotracheal tube leak greater than 15%
- Lack of informed consent from parents
- Severe lung hypoplasia or interstitial lung disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
German Heart Center of the Charité
Berlin, Germany, 13353
Actively Recruiting
Research Team
J
Jan C Clausen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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