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临床试验/NCT01496027
NCT01496027已完成不适用

A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)

研究概览

简要总结

The aim of the study is to compare the values of cerebral tissue oxygenation measured simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Day 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • Clinically stable
  • Spontaneously breathing newborns

排除标准

  • Congenital heart defects or anomalies of central nervous system
  • Prematurity below 32 GA
  • Respiratory distress

结局指标

主要结局

Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)

时间窗: 6 hours

There are two FDA-approved near infrared cerebral oximeters: 1. FORE-SIGHT- which uses laser light 2. INVOS 5100- which uses light emmiting diode. Measurements in adult patients have showed that FORE-SIGHT provides more stable signal. Purpose of our study is to compare these two devices in newborn patients.

次要结局

未报告次要终点

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomasz Szczapa

M.D.

Poznan University of Medical Sciences

研究点 (1)

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