Investigative Neurological Study With Pupillometric Evaluation os a Clinical Tool in Patients Declared Brain Dead (INSPECT) - a Prospective Quality Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Reliability of clinical examination of pupils in patients with suspected brain death
研究概览
简要总结
The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.
详细描述
This prospective quality control study will evaluate the reliability of the clinical exam regarding pupils' reaction to light (as performed by two board certified physicians in Neurology and/or Intensive Care Medicine) as recommended by the SAMW guidelines for brain death diagnosis (SAMW-guidelines) when compared to the results of a noninvasive automated and highly-precise pupillometry in adult patients with clinically suspected brain death. Automated pupillometric measurements will be performed by the PI (RS), or the co-investigator (Dr. Pascale Grzonka) using the NeurOptics® NPi®-200 pupillometer system immediately before and after the standardized diagnostic workup for suspected brain death. In addition, demographics, clinical characteristics , treatment and laboratory data from the patients examined will be anonymously collected.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected diagnosis of brain death
- •Brain death diagnostic procedures planned
- •Treated at the intensive care unit at the University Hospital Basel (USB)
排除标准
- 未提供
结局指标
主要结局
Reliability of clinical examination of pupils in patients with suspected brain death
时间窗: baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation)
Determination of the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death compared to the results of a noninvasive, automated, and highly precise pupillometric examination (measurement of the discordance between automated analyses of pupillary light reflex by a hand-held pupillometer and visual examination without pupillometer support in percentage)
次要结局
未报告次要终点