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NCT Number: NCT07486167

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

The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.

The primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.

Secondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.

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Key information

About this study

Cardiopulmonary bypass is associated with interruption of ventilation, leading to atelectasis, reduced end-expiratory lung volume, and increased pulmonary vascular resistance (PVR), which may impair right ventricular (RV) performance and overall cardiac output.

This study investigates whether a structured LVOM strategy can mitigate these effects by improving lung mechanics and cardiopulmonary interactions.

Specific Aims

Aim 1:

To quantify changes in hemodynamics and lung mechanics induced by LVOM under standardized postoperative (closed-chest) conditions.

Aim 2:

To compare individualized PEEP titration versus standard ventilation in terms of effects on hemodynamics and lung mechanics, while maintaining consistent tidal volume targets across groups.

Hypotheses

LVOM will improve lung mechanics and hemodynamic parameters. No significant between-group differences are expected prior to intervention. After PEEP titration, the intervention group will demonstrate superior cardiopulmonary function at moderate PEEP levels, reflecting the U-shaped relationship between lung volume and pulmonary vascular resistance (PVR).

Scientific Rationale

Cardiopulmonary bypass commonly results in atelectasis and loss of end-expiratory lung volume, contributing to increased PVR and RV afterload, with subsequent reduction in cardiac output.

Adult studies suggest that lung volume optimization through PEEP titration after CPB can improve cardiac index and RV performance. However, prospective pediatric data evaluating the interaction between ventilatory strategy, lung mechanics, and hemodynamics remain limited.

Given the central role of the right ventricle in coupling pulmonary and systemic circulation, optimizing lung volume may reduce RV afterload and improve overall cardiac performance.

Importantly, pulmonary vascular resistance follows a U-shaped relationship with lung volume, with increased resistance at both low (atelectasis) and high (overdistension) lung volumes. Individualized PEEP titration may therefore identify an optimal range that minimizes PVR while preserving hemodynamic stability.

This study addresses a critical gap by systematically evaluating cardiopulmonary interactions under contemporary ventilation strategies in pediatric cardiac surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

End-expiratory lung volume optimization maneuver with PEEP titration

Procedure

PEEP titration (incremental/decremental) will be performed at the end of surgery to optimize lung volume and find levels of PEEP corresponding to the "best" lung compliance and "best" compromise of overdistension and collapse and "best" homogenization of tidal volume distribution assessed with EIT. PEEP levels will be applied based on individual response of patients' lung mechanics and EIT measures. 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.

Standard Care (in control arm)

Procedure

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.

Primary outcomes

  1. Cardiac Index (L/min/BSA)

    Time frame: perioperatively

    assessed by using POCUS

Secondary outcomes

  1. lung mechanics

    Time frame: perioperatively

    lung compliance (ml/cmH2O/kg)

  2. right ventricular performance

    Time frame: perioperatively

    TAPSE PAAT Strain

  3. ventilation distribution

    Time frame: perioperatively

    EIT

  4. lung perfurision

    Time frame: perioperatively

    EIT

  5. dead space fraction

    Time frame: perioperatively

    pulmonary dead-space fraction (Vd/Vt)

  6. avDO2

    Time frame: perioperatively

    difference in arteriovenous oxygen content

Study contacts

Contact information is provided by the study sponsor or research team.

Jan C Clausen, MD

CONTACT

[email protected]

00493045932800

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease

Acronym: ILOCO-CHD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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