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

Mechanical Ventilation Congenital Heart Disease Children ARDS Cardiac Surgery Cardiopulmonary Bypass Positive End-expiratory Pressure (PEEP)Lung Volume Lung Mechanics Hemodynamic Changes ECMO

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

Inclusion Criteria5

CHD study:
congenital heart disease
surgery with cardiopulmonary bypass
patients with respiratory failure on ECMO or at risk for ECMO
invasive ventilation

Exclusion Criteria7

single ventricle physiology
ECMO/VAD
<36weeks of gestational age
chronic lung disease
Endotracheal tube leak > 15%
lack of informed consent from parents.
\- severe lung hypoplasia or interstitial lung disease

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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