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临床试验/NCT02803359
NCT02803359已完成不适用

Investigation of Human Laryngeal Evoked Brainstem Potentials

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年6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
14
试验地点
1
主要终点
analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodes

研究概览

简要总结

The primary purpose of this study will be to determine whether the proposed study protocol will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR). Laryngeal evoked brain stem responses will be recorded from five test subjects under general anesthesia in the operating room with the assistance of an electrophysiologist with expertise in evoked potentials. Once the feasibility of obtaining tracings are established on the first few subjects, responses will be recorded from other test subjects with the aim of determining the optimal placement of stimulating electrodes and detection leads necessary to elicit an adequate response. The effect of varying the stimulus intensity will also be studied. Once parameters for testing have been standardized, normative configurations for the laryngeal evoked brainstem response tracings can be determined by patients both in the office setting and in the operating room.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy Subjects undergoing thyroid or other open neck surgeries

排除标准

  • Current or recent (within one month) tracheostomy
  • Vocal cord paralysis
  • History of Stroke
  • History of Diabetes Mellitus
  • History of Neurologic Disease
  • History of Radiation to the Neck
  • History of Brain Surgery
  • History of Neck Surgery
  • Recent Laryngeal Surgery (within one month)
  • Recent Intubation (within two weeks)
  • Laryngopharyngeal Reflux Disease
  • Allergy to Lidocaine
  • Allergy to Oxymetazoline

结局指标

主要结局

analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodes

时间窗: One Year

Distributions of latencies within this group will be examined to evaluate the appropriateness of standard assumptions regarding normality and constant variance, and transformations or non-parametric statistics will be considered as needed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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