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临床试验/NCT07486167
NCT07486167
尚未招募
1 期

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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年9月1日最近更新:

概览

阶段
1 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Cardiac Index (L/min/BSA)

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Statisticians

入排标准

年龄范围
0 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria
  • congenital heart disease
  • surgery with cardiopulmonary bypass

排除标准

  • single ventricle physiology
  • \<36weeks of gestational age
  • chronic lung disease
  • Endotracheal tube leak \> 15%
  • lack of informed consent from parents.

研究组 & 干预措施

Control

Active Comparator

This group receives so called standard of care. This includes relatively low levels of PEEP (5cmH2O in case of planned surgery) and no standardized PEEP titration.

干预措施: Standard Care (in control arm) (Procedure)

Treatment

Experimental

This group receives an individual lung volume optimization maneuver with PEEP titration. PEEP titration is performed while monitoring lung mechanics and EIT indices of overdistension and collapse and regional tidal volume distribution to optimize end-expiratory lung volume and find final "best PEEP". If possible lung perfusion will be assessed with EIT to evaluate V/Q-matching.

干预措施: End-expiratory lung volume optimization maneuver with PEEP titration (Procedure)

结局指标

主要结局

Cardiac Index (L/min/BSA)

时间窗: perioperatively

assessed by using POCUS

次要结局

  • lung mechanics(perioperatively)
  • right ventricular performance(perioperatively)
  • ventilation distribution(perioperatively)
  • lung perfurision(perioperatively)
  • dead space fraction(perioperatively)
  • avDO2(perioperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Clausen

Principal Investigator

Charite University, Berlin, Germany

研究点 (1)

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