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临床试验/NCT02329028
NCT02329028已完成不适用

Feasibility of Mini-EEG in the Prehospital Setting

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年1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
23
试验地点
1
主要终点
Device ease-of-use

研究概览

简要总结

The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Standard EEG devices are large and their operation require meticulous application of several leads. The department of clinical neurophysiology at Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency department as well as in the prehospital setting. The aims of this pilot study is to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes are used. The sample size is 30. Data are collected as a part of the clinical work in daily practice. The aim is to collect observational data on feasibility, no clinical interventions will be performed based on the EEG. No funding is needed as data is collected during daily work.

The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central Hospital, and as such, does not have a trade name. It is to be connected to a monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by Physio-Control, Redmond, WA 98052. (www.physio-control.com)

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

入选标准

  • Unconsciousness resulting in activation of the local EMS units

排除标准

  • Cardiac arrest
  • Traumatic unconsciousness
  • Transient unconsciousness

结局指标

主要结局

Device ease-of-use

时间窗: 60 min

evaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)

Signal interpretability

时间窗: 60 min

evaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)

次要结局

未报告次要终点

研究者

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

Johannes Björkman

Resident

Helsinki University Central Hospital

研究点 (1)

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