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临床试验/NCT03175965
NCT03175965已完成不适用

Characteristics of the Somatosensory Evoked Potentials Indicating Poor Neurologic Outcome After Cardiac Arrest

Uijeongbu St. Mary Hospital4 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
4
主要终点
Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation

研究概览

简要总结

This study aims to examine whether P30 wave of somatosensory evoked potentials (SEP) is related with outcome after cardiac arrest. The study design is a prospective, multicenter-observational study. Patients survived after out-of-hospital cardiac arrest undergoing hypothermic-targeted temperature management will participate in the study. Relationship of P30 wave of SEP with the neurologic outcome on hospital discharge will be evaluated.

详细描述

The absence of N20 of the somatosensory evoked potentials (SEP) is recommended as a valuable predictor of poor neurologic outcome in post-cardiac arrest patients. However, interpretation of N20 is affected by the background noise levels. Reliable analysis of N20 is limited with high noise levels and artifacts. Moreover, presence of N20 does not guarantee good neurologic outcome. P30 is a positive deflection of N20 occurring on 25-35 msec. According to our pilot study, N20 without following P30 is related with poor outcome, while N20 followed by P30 is highly related with good outcome. P30 is evident even when the N20 is ambiguous in patients with good outcome. We hypothesized that the negative-positive deflection of N20-P30 components is more valuable predictor than the N20 alone. In this observational study, we will identify whether presence of P30 checked on 24 and 72 hours after cardiac arrest predicts neurologic outcome more accurately than the presence of N20 alone.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Comatose survivors after out-of-hospital cardiac arrest

排除标准

  • Not treated by hypothermic-targeted temperature management

结局指标

主要结局

Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation

时间窗: 72 hours after ROSC

SEP under the normothermic-TTM without sedation

次要结局

  • Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation(72 hours after ROSC)
  • Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation(24 hours after ROSC)
  • Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation(24 hours after ROSC)

研究者

发起方
Uijeongbu St. Mary Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joo Suk Oh, MD. PhD.

Associate Professor

Uijeongbu St. Mary Hospital

研究点 (4)

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