跳至主要内容
临床试验/NCT05601622
NCT05601622尚未招募不适用

Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children

Seoul National University Hospital0 个研究点目标入组 45 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
AUC of ROC curve

研究概览

简要总结

The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.

详细描述

Children undergoing surgery under general anesthesia will be enrolled. After anesthetic induction, they will be assessed via transthoracic echocardiography for measurement of the patient's stroke volume index (SVI). Also, pleth variability index and Rainbow pleth variability index will be measured under mechanical ventilation with tidal volume of 6, 8, 10 ml/kg.

To exert fluid loading, 10ml/kg of crystalloid solution will be administered intravenously over 10 minutes. After fluid loading, the SVI will be measured again and fluid responsiveness will be determined according to increment ratio of the SVI.

According to the determined fluid responsiveness, predictive power of pleth variability index and Rainbow pleth variability index for fluid responsiveness will be assessed by building a receiver-operating characteristics curve.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children undergoing neurosurgery under general anesthesia

排除标准

  • Presence of any cardiovascular disease
  • Presence of any pulmonary disease
  • Decline of enrollment from any of the patient's parents

结局指标

主要结局

AUC of ROC curve

时间窗: From start of anesthesia to end of anesthesia, Less than 24 hours

Area under the curve of the receiver-operating characteristics curve of pleth variability index and Rainbow pleth variability index for prediction of fluid responsiveness

次要结局

  • SpO2(From start of anesthesia to end of study, Less than 24 hours)
  • Appearance of abnormal heart rhythm(From start of anesthesia to end of study, Less than 24 hours)
  • IBP(From start of anesthesia to end of study, Less than 24 hours)

研究者

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

Hee-Soo Kim

Professor

Seoul National University Hospital

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