Use Of A Point-Of-Care TBI Detection System For Identification Of Head Injured Patients Who Present To The Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 11
- 主要终点
- Extend and replicate a database of brain electrical activity and clinical information collected from patients who present to the ED following closed head injury
研究概览
简要总结
A prospective, non-randomized trial for the extension and replication of the development database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.
详细描述
The objective of this study is to test the clinical utility of the BrainScope technology for the acute identification of traumatic structural brain injury in the TBI population, following closed head injury. The data generated will serve to validate and/or refine the current algorithms to detect acute, traumatic, structural brain injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 24 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).
排除标准
- •Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.
- •In addition,
- •subjects with dementia,
- •Parkinson's Disease,
- •multiple sclerosis,
- •seizure disorder,
- •brain tumors,
- •history of brain surgery,
- •psychiatric disorder being managed by a psychiatric healthcare professional/provider,
- •substance dependence,
- •history of TIA or stroke within the last year,
- •currently receiving dialysis or in end-stage renal disease,
- •active fever defined as greater than 100 degrees F or 37.7 degrees C,
- •current condition is "critical" in the opinion of the investigator,
- •subject is suffering from an open head injury,
- •subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications.
- •Subjects below the age of 18 years, and prisoners will not be eligible for study.
结局指标
主要结局
Extend and replicate a database of brain electrical activity and clinical information collected from patients who present to the ED following closed head injury
时间窗: 30 days
次要结局
未报告次要终点