Prospective Pilot Trial to Evaluate the NeurOptics Pupillometer and Clinical Examination of the Pupillary Reflex After Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Neurological Pupil index (NPi) on a scale from 0-5
研究概览
简要总结
The trial will evaluate the use of the "Neurological Pupil index" NPi, measured with the digital pupillometer (NeurOptics) compared to clinical examination for better reliability. The investigators hypothesize that digital evaluation will offer a higher sensitivity/ specificity compared to clinical examination.
详细描述
Absent pupillary reaction after cardiac arrest might indicate a severe hypoxic encephalopathy. Because the examination of the pupillary reaction is easy it is part of the clinical routine but due to the different medication and the dynamic process of reperfusion injury to the brain a clinical evaluation might be not precise enough. The NPi has been shown to be superior to clinical evaluation in different settings but without regard towards cardiac arrest survivors. The Pupillometer is a hand-held, cordless, and simple to use device which removes subjectivity in the measurement of pupil size and the pupillary light reflex.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all survivors after cardiac arrest
排除标准
- •underlying disease limiting the pupillary reflex
结局指标
主要结局
Neurological Pupil index (NPi) on a scale from 0-5
时间窗: up to 7 days
NPi values by the device on a scale by 0-5; \>3 indicates normal reaction; \<3 abnormal.
次要结局
- Cerebral performance category (CPC)(Patients will be followed for the duration of hospital stay, an expected average of 2 weeks)
研究者
C. Storm
Principal Investigator
Charite University, Berlin, Germany
