跳至主要内容
临床试验/NCT03534258
NCT03534258已完成不适用

Does Use of Rapid Response EEG Impact Clinical Decision Making

Ceribell Inc.5 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年4月30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
164
试验地点
5
主要终点
Change in physicians' diagnosis decision

研究概览

简要总结

This study is designed as a prospective, non-randomized, observational, multicenter clinical trial. The primary aim of this study is to observe if the use of the rapid responds electroencephalography (EEG) system impacts physician decision making. Secondary aims include exploring the safety and performance information of the Ceribell EEG system compared to conventional EEG system. The study will recruit physicians (Faculty physicians and Trainees) at up to five institutions and examine the impact of rapid response EEG when providing care to patients in whom EEG recording has been ordered for clinical reasons.

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

  • Patients undergoing clinically ordered EEGs.

排除标准

  • 未提供

结局指标

主要结局

Change in physicians' diagnosis decision

时间窗: through study completion, an average of 1 year

Physician will record their diagnostic assessment of seizure in Yes or No.

Change in physicians' diagnosis confidence

时间窗: through study completion, an average of 1 year

Physician will rate their diagnosis confidence with a score between 1 to 5

Change in physicians' treatment decision

时间窗: through study completion, an average of 1 year

Physician will record their treatment decision in Yes or No.

Change in physicians' treatment confidence

时间窗: through study completion, an average of 1 year

Physician will rate their treatment confidence with a score between 1 to 5

次要结局

  • Time from order to EEG arrival(through study completion, an average of 1 year)
  • Set up time(through study completion, an average of 1 year)
  • Ease of use(through study completion, an average of 1 year)
  • Signal Quality of EEG(through study completion, an average of 1 year)

研究者

发起方
Ceribell Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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