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Influence of Lung Volume Optimization Maneuver in Ventilated Children on Cardiac Output and Lung Compliance in Children With Congenital Heart Disease Undergoing Surgical Repair and in Children Requiring ECMO for Respiratory Failure

Influence of Lung Volume Optimization Maneuver in Ventilated Children on Cardiac Output and Lung Compliance in Children With Congenital Heart Disease Undergoing Surgical Repair and in Children Requiring ECMO for Respiratory Failure

Recruiting
18 years and younger
All
Phase 1/2

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Overview

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver is beneficial in children undergoing biventricular repair of their congenital heart disease and in children on ECMO.

The main questions it aims to answer are:

  1. Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:
    • cardiac performance
    • lung function
  2. Does it make a difference in:
    • length of ventilation
    • ventilation/perfusion mismatch of the lung
    • need for vasopressor support?

Description

The objective of this study is to define the impact of variable levels of PEEP and on hemodynamics and lung mechanics in children with congenital heart disease (CHD) undergoing surgery and in those needing ECMO.

The Specific Aims of this work are:

Specific Aim 1:

Evaluate hemodynamics and lung mechanics during and after a LVOM:

In cases of children undergoing cardiac surgery all measurements will be performed with closed chest conditions.

Specific Aim 2:

Evaluate a potential benefit of lung volume optimization by performing PEEP titration on hemodynamics and lung mechanics compared to standard care without PEEP titration to optimize end-expiratory lung volume.

Hypotheses
  1. Hemodynamics and lung mechanics will be significantly different before and after LVOM. We expect that there will be little difference between intervention and control group before performing PEEP titration in the interventional group.
  2. Once the PEEP titration has been performed in the interventional group, we hypothesize that patients who received the intervention will have improved hemodynamics and lung mechanics with modest PEEP while receiving the same tidal volume than the control group (U-shaped curves).

Rationale: Surgery with cardiopulmonary bypass typically involves an interruption of mechanical ventilation while CPB is running. This is oftentimes associated with atelectasis formation and impaired gas exchange due to reduced end-expiratory lung volume. While there have been few studies in adults that have shown that optimization of lung volume by performing PEEP titration after CPB can significantly improve Cardiac Index and right ventricular function, there have been only very few prospective pediatric studies which assessed the impact of different PEEP settings on hemodynamics, and lung mechanics after cardiac surgery in children. Because these patients are generally among the most fragile postoperative patients, it is critical to understand if specific ventilator strategies can help mitigate any negative hemodynamic consequences after surgery. The purpose of this study is to understand the critical cardiopulmonary interactions that occur with changes in lung volumes, and to determine optimal approaches to mechanical ventilation under these different circumstances.

Cardiopulmonary interactions differ based on the underlying cardiac anatomy and physiology. Most studies of cardiopulmonary interactions following surgery for congenital heart disease have examined the difference between positive and negative pressure ventilation. This work consistently showed improvement in cardiac output and pulmonary blood flow with negative pressure ventilation, while positive pressure ventilation was associated with decreased cardiac output. However, these studies have been conducted in the 1990's and positive pressure ventilation has changed significantly in the meantime.

Similarly, while patients with left ventricular dysfunction generally benefit from positive pressure ventilation, there is little data regarding the hemodynamic effects of positive pressure ventilation on right ventricular performance.

Modulating pulmonary vascular resistance by optimizing lung volumes might be a promising approach to improve both lung mechanics and hemodynamics. Studies in this population have focused more on the effects of FiO2 and hyperventilation than on respiratory mechanics and cardiopulmonary interactions.

Children and infants with ARDS requiring ECMO usually have reduced lung volumes. Optimizing lung volumes by performing a LVOM might be beneficial to wean ECMO faster or even prevent its need.

Eligibility

Group 1 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.

Group 2 Inclusion Criteria

  • patients with respiratory failure on ECMO or at risk for ECMO
  • invasive ventilation

Exclusion Criteria:

\- severe lung hypoplasia or interstitial lung disease

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

NCT07193719

Charite University, Berlin, Germany

1 February 2026

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