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临床试验/NCT01897194
NCT01897194已完成不适用

A Wireless EEG Patch Device for Continuous Electrographic Monitoring and Study of Coma in the Neurocritical Care Unit

University of Utah0 个研究点目标入组 1 人开始时间: 2013年7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
1
主要终点
Emergence from coma

研究概览

简要总结

Despite its clinical significance, the pathophysiology of coma is still under investigation and the physiology of emergence from coma remains a mystery. Furthermore, predictors of emergence from coma, despite their obvious clinical value, remain un-established. Because of its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has been studied as both an animal and human model of coma, and awakening from sleep has likewise been studied as a surrogate of coma emergence. In this study, we will determine whether certain electrographic patterns, known as spectral shifts, which have correlates in normal sleep, are predictive of eventual awakening from coma and the time course of this emergence. To detect spectral shifts in comatose patients, EEG monitoring must be performed for several days. Quick, simple, and reliable EEG recording in the ICU will be enhanced by a small device that can be easily and properly positioned on the head by hospital personnel and which lacks cumbersome cables or receivers. Traditional EEG monitoring requires placement of up to 25 wires, which can impede efficient intensive patient care. Our hypothesis is that we can detect a difference in spectral shifts in comatose patients who will eventually emerge from coma as compared to comatose patients who do not wake up and that a wireless EEG patch-type device can effectively make this distinction.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • All patients with brain injuries admitted to the neurocritical care unit will be screened for enrollment. The estimated enrollment will be for 100 patients. 90 patients will be comatose with Glascow Coma Scale <
  • The other 10 patients will be control, non-comatose patients for quality control of the device. Consent for inclusion will be obtained from the patient or next of kin for all enrolled patients.

排除标准

  • 未提供

结局指标

主要结局

Emergence from coma

时间窗: 1 year post admission

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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