Ceribell Delirium Data Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Perform Electroencephalogram (EEG) Test
研究概览
简要总结
This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.
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
- 否
入选标准
- •All must be present
- •Age is 18 years or older
- •Admitted to the Intensive Care Unit (ICU)
- •Subject must be fluent in the language in which the delirium assessment is performed
排除标准
- •All must be absent
- •Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.
结局指标
主要结局
Perform Electroencephalogram (EEG) Test
时间窗: 6-8 hours per day, for a maximum of six (6) days
Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients.
Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment
时间窗: 3 times per day, for a maximum of six (6) days
Research coordinator will perform and collect CAM-ICU assessment data on study subjects
次要结局
未报告次要终点