Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of delayed cerebral ischemia (DCI)
研究概览
简要总结
The pupilometer determines the alteration of the pupil diameter after a defined light stimulus. In this study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during daily neurological routine examinations. The values are compared to outcomes resulting from pupilometer measurements done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without symptoms). The study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.
详细描述
The pupilometer determines the alteration of the pupil diameter after a defined light stimulus providing information of the autonomic nerve system. The result collecting from pupillometry is objective and more precise than the subjective-visual evaluation of the pupil and its reactivity.
In this observational study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during neurological routine examinations. The first measurement is done during the initial diagnosing examination, followed by daily measurements and ending with measurements after 3 and 6 month upon hospital discharge. The values are compared to standard values resulting from pupilometer measurements done on patients having non-acute cerebral disease (e.g. cerebral aneurysm without symptoms). The study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.
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
- •male or female patient, age ≥ 18 years
- •signed consent
- •treatment group:
- •patient with acute, cerebral disease verified by CT, MRI or spinal tap
- •control group
- •patient with non-acute cerebral disease like a new diagnosed aneurysm without symptoms
排除标准
- •female or male patient aged < 18 years
- •absent of signed consent
- •persons who have a dependent or working relationship with the sponsor or investigator
- •persons who are sheltered in an institution by juridical or governmental order
- •concurrent participation in an other clinical study
结局指标
主要结局
Number of delayed cerebral ischemia (DCI)
时间窗: 21 days
DCI is defined as the development of new focal neurological signs and/or deterioration in level of consciousness, lasting for more than 1 h, or the appearance of new infarctions on CT or MRI.
Number of perfusion deficiency
时间窗: 21 days
次要结局
- Transcranial Doppler (TCD) -fluency increase [cm/s](21 days)
- Digital subtraction angiography (DSA)(day 7 ± 2 d)
- Glasgow Outcome Score (GOS)(after 3 and 6 month)
研究者
Gerrit Alexander Schubert
apl. Prof. Dr. med. Gerrit Alexander Schubert
RWTH Aachen University