Validation Of Point-Of-Care TBI Detection System For Head Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 981
- 试验地点
- 11
- 主要终点
- The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury.
研究概览
简要总结
A prospective, non-randomized trial to validate the 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 validate the clinical utility of the BrainScope technology for the acute identification of structural brain injuries in a TBI population presenting to the ED with mild symptoms, following closed head 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 72 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,
- •evidence of acute psychosis,
- •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
The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury.
时间窗: 30 days
The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.
次要结局
- To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).(30 days)
- To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score.(30 days)