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

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

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age0-18

SponsorCharite University, Berlin, Germany

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

congenital heart disease

surgery with cardiopulmonary bypass

Disqualifiers

single ventricle physiology

ECMO/VAD

<36weeks of gestational age

chronic lung disease

Trial design

Design model

Parallel

Treatments tested in this trial

End-expiratory lung volume optimization maneuver with PEEP titration
Procedure/Surgery
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) .
Standard Care (in control arm)
Procedure/Surgery
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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: controlActive comparator 1 intervention

Group B: treatmentExperimental treatment 1 intervention

Trial outcomes