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

RecruitingPhase 1, Phase 2Ages 0 Years - 18 YearsAllCharite University, Berlin, Germany
NCT07193719 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
CHD study: 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. 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
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What it tests

  • End-expiratory lung volume optimization maneuver with PEEP titration
  • Standard Care (in control arm)
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Where

1 site
Unviersity of Tuebingen, PICU
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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