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

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

Conditions

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

Interventions

PROCEDURE

End-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) .

PROCEDURE

Standard 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

Sponsors & Collaborators

• Charite University, Berlin, Germany

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-05

Primary Completion

2027-05-31

Completion

2027-12-20

Countries

• Germany

Study Locations