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临床试验/NCT03154879
NCT03154879Unknown不适用

Prospective Multi-center Study to Verify Neurological Prognostic Value of Amplitude-integrated Electroencephalogram in Cardiac Arrest Patients Treated With Therapeutic Hypothermia

Seoul St. Mary's Hospital4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
4
主要终点
Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2

研究概览

简要总结

The investigators examine the prognostic value of continuous electroencephalography on frontal area of brain according to time by performing amplitude-integrated electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia.

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

  • age: 19 years and older
  • underwent TH

排除标准

  • Died within 72 h after cardiac arrest
  • Spontaneous or traumatic brain injury
  • Known history of neurological diseases (such as epilepsy)

结局指标

主要结局

Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2

时间窗: at day 180

Time to normal trace is defined as time to regained normal trace on aEEG after return of spontaneous circulation. The normal trace is defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was \>10 uV, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was \>5 uV.

次要结局

  • Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)

研究者

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

Kyu Nam Park

Professor

Seoul St. Mary's Hospital

研究点 (4)

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