Evaluation of a Wireless EEG Monitor for Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent Agreement
研究概览
简要总结
The purpose of this study is to understand if a new, smart, wireless EEG developed by our team can be used to monitor the continuous electrical activity of the brain in the ICU and EMU and whether it works as well as the current standard, wired EEGs.
详细描述
The investigators propose to 1) optimize these devices for use in pediatric ICU patients, 2) demonstrate safety, reliability, and accuracy of these devices for continuous ICU EEG signal measurements, and 3) demonstrate these devices are preferred by patients and parents to current EEG devices. Once validated, such sensors could fundamentally change the way patients are monitored by EEG in the ICU, allowing wireless, continuous, real-time detection of brain wave activity in ICU patients, reducing limitations in mobility as well as access by staff and caregivers to the patient, and ultimately offering opportunity to reduce morbidity and mortality in ICU patients.
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be admitted to the PICU or EMU at Lurie Children's and are prescribed an EEG as part of their standard of care.
排除标准
- •Anyone with a skin abnormality that would potentially increase the risk of device use will be excluded.
- •Ages 18 years or older.
- •Any patient or family determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family) will not be approached for recruitment.
结局指标
主要结局
Percent Agreement
时间窗: 3 years
Percent agreement between experimental sensor and commercially available electroencephalogram (EEG)
次要结局
未报告次要终点
研究者
Shuai (Steve) Xu
Principal Investigator
Northwestern University