NCT06918457尚未招募不适用
A Clinical Trial With a Self-controlled, Multicenter, Pediatric EEG Intelligent Analysis System to Assist in Diagnosis
Kunming Children's Hospital0 个研究点目标入组 1,000 人开始时间: 2025年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- To evaluate the coincidence rate between doctors' independent diagnosis and the diagnosis recommended by the AI system.
研究概览
简要总结
A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age < 18 years old
- •Children with suspected epilepsy
排除标准
- •During EEG monitoring, the patients had other serious neurological diseases and mental diseases concurrently
- •Used medication that affect EEG data within 3 weeks, such as sedatives and anti-epileptic medications
- •Substandard data quality, such as data lack of key records, electrode connection discontinuity, insufficient recording time, or the presence of serious artifacts
- •Incomplete or missing data
- •Equipment or operational abnormalities, data for which EEG monitoring has not been performed continuously
结局指标
主要结局
To evaluate the coincidence rate between doctors' independent diagnosis and the diagnosis recommended by the AI system.
时间窗: Within 48 hours after the completion of EEG monitoring
The reference standard is the EGG interpreted by 3 clinicians who had attended the uniformly training program and had more than 5 years of experience in diagnosing epilepsy in children.
次要结局
- To evaluate the diagnostic efficiency of clinicians at two-stage(Immediately after the end of EEG interpretation)
研究者
Xiaomei Liu
Professor
Kunming Children's Hospital
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