Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Stroke volume index
研究概览
简要总结
This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery.
详细描述
Pressure-based dynamic variables such as pulse pressure variation(PPV) and systolic pressure variation(SPV) are known to be unreliable for prediction of fluid responsiveness in children.
The hypothesis is that tidal volume change in mechanically ventilated children undergoing anesthesia would affect reliability of aforementioned dynamic variables in prediction of fluid responsiveness, especially in the way that reliability increases for high tidal volume.
In children undergoing cardiac surgery, tidal volume is changed to 6mL/kg, 10mL/kg and 14mL/kg after closure of sternum, followed by measurement of PPV, SPV. We also measure the respiratory variation of aortic blood peak velocity(△Vpeak) via transesophageal echocardiography, which is known to best predict fluid responsiveness.
Afterward, 10mL/kg of crystalloid solution is administered for fluid loading. 'Fluid responder' is defined as subjects with increase of stroke volume index more than 15% after fluid loading of 10mL/kg.
With these data, whether the predictability of fluid responsiveness of PPV and SPV changes according to change in tidal volume is evaluated by comparing the area under the curve of the receiver-operating characteristics curve between themselves and △Vpeak.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children younger than 6 years old planned to undergo ventricular septal defect closure or atrial septal defect closure under general anesthesia
排除标准
- •Children with other complex cardiac defects
- •Children with arrhythmia
- •Children with preoperatively measured ejection fraction of less than 30%
- •Children with underlying pulmonary disease
结局指标
主要结局
Stroke volume index
时间窗: From sternal closure to 5 minutes after fluid loading
Define subject that shows increase of stroke volume index more than 15% after 10mL/kg of fluid loading as fluid responder, otherwise as non-responder
Predictability_PPV and SPV
时间窗: From sternal closure to 5 minutes after fluid loading
Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of pulse pressure variation and systolic pressure variation after each change of set tidal volume
次要结局
- Predictability_△Vpeak(From sternal closure to 5 minutes after fluid loading)
- Grey zone(From sternal closure to 5 minutes after fluid loading)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital