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

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

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07486167
Acronym
ILOCO-CHD
Enrollment
80
Registered
2026-03-20
Start date
2026-09-01
Completion date
2028-12-31
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass, Children, Congenital Heart Disease, Hemodynamic Changes, Lung Mechanics, Lung Volume, Mechanical Ventilation, Peep Titration in Lung Protective Ventilation, Positive End-expiratory Pressure (PEEP)

Keywords

cardiopulmonary interactions, end-expiratory lung volume, electrical impedance tomography, PEEP titration

Brief summary

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.

Detailed description

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.

Interventions

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.

PROCEDUREStandard Care (in control arm)

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.

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Statisticians

Intervention model description

The type of intervention is one of clinical management (ventilatory management) and does not include a specific drug or biological

Eligibility

Sex/Gender
ALL
Age
0 Days to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Index (L/min/BSA)perioperativelyassessed by using POCUS

Secondary

MeasureTime frameDescription
lung mechanicsperioperativelylung compliance (ml/cmH2O/kg)
right ventricular performanceperioperativelyTAPSE PAAT Strain
ventilation distributionperioperativelyEIT
lung perfurisionperioperativelyEIT
dead space fractionperioperativelypulmonary dead-space fraction (Vd/Vt)
avDO2perioperativelydifference in arteriovenous oxygen content

Countries

Germany

Contacts

CONTACTJan C Clausen, MD
jan.clausen@posteo.de00493045932800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026