Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease
试验速览
- 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)
研究概览
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.
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
- 否
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
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
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
Jan Clausen
Principal Investigator
Charite University, Berlin, Germany