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临床试验/NCT01820845
NCT01820845已完成不适用

Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge.

研究概览

简要总结

Plethysmographic Variability index is a simple index accurate in predicting fluid responsiveness.

The aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

详细描述

The goal of the present study is to assess the validity of PVI in predicting the response to a fluid challenge during scoliosis surgery in children.

During this observational non-interventional study, each fluid challenge will be monitored by esophageal Doppler and PVI (Massimo Radical 5).

Anesthesia, surgery and intraoperative fluid administration id standardized according to our clinical protocol.

An increase in indexed Stroke Volume (iSV) by more than 15 % will define the positive response to the fluid challenge.

Fluid challenges will be performed in the supine position and in the prone position.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Scoliosis surgery
  • Age < 18 years

排除标准

  • Heart or vascular Diseases
  • Rectal abnormalities
  • Kidney Failure
  • Neuromuscular scoliosis

结局指标

主要结局

Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge.

时间窗: During the intraoperative period.

Data will be used to assess the accuracy of Plethysmographic Variability Index in predicting fluid challenge.

次要结局

  • Indexed Stroke volume before each fluid challenge and percentage of variation in indexed Stroke volume during each fluid challenge.(During the intraoperative period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Accuracy of Pleth Variability Index (PVI) in Children | 临床试验