RecruitingPhase 1Phase 2NCT07193719

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

Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children


Sponsor

Charite University, Berlin, Germany

Enrollment

80 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 0 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a special breathing (lung volume) technique used during mechanical ventilation improves heart function and lung flexibility in two groups: children with congenital heart disease undergoing heart surgery, and children with severe respiratory failure who are on or at risk of needing ECMO (a life support machine that does the work of the heart and lungs). **You may be eligible if...** - For the heart surgery group: your child has congenital heart disease and is having surgery requiring a heart-lung bypass machine - For the ECMO group: your child has severe respiratory failure and is on ECMO or at serious risk of needing it, and is on mechanical ventilation **You may NOT be eligible if...** - Your child has a single-ventricle heart defect (for the heart surgery group) - Your child is already on ECMO or a ventricular assist device (VAD) (for the heart surgery group) - Your child was born premature (before 36 weeks) - Your child has chronic lung disease or severe lung underdevelopment - A parent or guardian has not provided informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEnd-expiratory lung volume optimization maneuver with PEEP titration

CHD study: PEEP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP corresponding to the best lung compliance at the end of surgery. Typically PEEP levels between 10-20cmH2O will be applied based on individual response of patients' lung mechanics. Tidal volume will be kept constant at 6ml/kg in cases and controls. Driving pressures will be limited to 15cmH2O. Balance of CO2 will be guaranteed by adjusting respiratory rate. ECMo study: PEEP/CDP titration (incremental/decremental) will be performed to optimize lung volume and find levels of PEEP/CDP corresponding to the best lung compliance, best match of overdistension and collapse and homogenization of tidal volume distribution (EIT) .

PROCEDUREStandard Care (in control arm)

CHD study: Patients will receive pressure controlled ventilation with target tidal volume of 6ml/kg and PEEP of 5cmH2O. Driving pressures are limited to 15cmH2O. No LVOM will be applied. ECMO study: patients will receive standard ECMO ventilation (PEEP 10cmH2O and PiP 20cmH2O) without performing LVOM


Locations(1)

German Heart Center of the Charité

Berlin, Germany

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NCT07193719


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