A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- To assess the feasibility of the neuromonitoring system and accuracy of the measurement values
研究概览
简要总结
To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring (NeMo Probe) and the accuracy of measurement values.
To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-75 years (inclusive)
- •Patients with high-grade subarachnoid hemorrhage (WFNS 4-5)
- •Decreased level of consciousness with the need for intracranial pressure monitoring
- •Successful exclusion of the ruptured aneurysm with clipping or coiling
- •Women of childbearing potential must have a negative serum pregnancy test
- •Written informed consent obtained by a legal representative
排除标准
- •Significant kidney and/or liver disease
- •Any severe unstable concomitant condition or disease (e.g. cancer, coronary disease) or chronic condition (e.g. psychiatric disorder, chronic obstructive pulmonary disease Grade II, chronic heart failure > NYHA II)
- •Cerebrospinal fluid infection or signs of meningoencephalitis
- •Acute respiratory distress syndrome (ARDS), pulmonary edema
- •Preexisting coagulation disorder
- •Patients with current alcohol or drug abusus or dependence
- •Patients with a history of hypersensitivity against indocyanine green or sodium iodine
- •Patients with thyroid disease causing hyperthyroidism
- •Breast-feeding women
- •Patients committed to an institution based on official directive or court order
结局指标
主要结局
To assess the feasibility of the neuromonitoring system and accuracy of the measurement values
时间窗: Day 90 after Removal of Medical Device
Feasibility: User acceptance rate in comparison to conventional probes for ICP-monitoring. The following parameters will be analysed: * Incidence of concerns of users in relation to the installation of the NeMo System * Incidence of concerns of users in relation to the function of the NeMo System Incidence of concerns of users in relation to the removal of the NeMo System * User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional probes for ICP monitoring Accuracy of measurement values: Results from repeated measurements of mttICG, CBV, and CBF. Safety endpoints: -Adverse events profile (including adverse device effects): Incidence of complications (infections, brain tissue damage, hemorrhage) in comparison to historical series (conventional probes for ICP-monitoring):
次要结局
- To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage(Day 90 after Removal of Medical Device)