Cervical Sympathetic Block to Increase Cerebral Blood Flow in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Cerebral blood flow
研究概览
简要总结
The purposes of this study are twofold: 1) to assess the effect of a cervical sympathetic block on cerebral blood flow in patients suffering from cerebral vasospasm, after aneurysmal subarachnoid hemorrhage; 2) to evaluate the effect of the sympathetic block on the recovery of the neurological function.
详细描述
Patients hospitalized in the intensive care unit (ICU) and developing clinical manifestations of cerebral vasospasm will be transferred to the neuro-interventional radiology suite for vasospasm treatment. After the vasospasm is confirmed by the angiography followed by a flat panel-computed tomography perfusion (FP-CTP) scan, a cervical sympathetic nerve block under ultrasound guidance will be performed.
The block consists of the deposition of local anesthetic at the cervical sympathetic ganglion that will be visualized with an ultrasound device. The local anesthetic solution with be mixed with a radiographic contrast agent to check the spread of the injectate in the desired anatomical location. The spread of the local anesthetic will be assessed by performing an 8-second head/neck C-arm CT scan. Following the block, another run of angiography and a second FP-CTP will be repeated to assess changes in vessels diameter and in perfusion parameters following the sympathetic block.
Patients will have a daily monitoring of their neurological function and of their cerebral blood flow with transcranial doppler in the ICU.
At 12 months post-aSAH, the patients will complete neurological and neuropsychological assessments as a part of the standard of care. The results of these tests will be collected for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •ages 18 and over
- •patients hospitalized in the ICU and developing cerebral vasospasm after aneurysmal subarachnoid hemorrhage
排除标准
- •- known advanced stage kidney disease
结局指标
主要结局
Cerebral blood flow
时间窗: 1 hour after the block
Cerebral blood flow as measured by computed tomography perfusion
Neurological function
时间窗: Duration of recovery in ICU (1-2 weeks)
Change in neurological status as assessed by the Glasgow Coma Scale. The Glasgow Coma Scale score can range from 3 (completely unresponsive) to 15 (responsive).
次要结局
- Cerebral blood flow velocity(Daily during recovery in ICU (1-2 weeks))
- Cerebral blood flow velocity(Daily during recovery in ICU (1-2 weeks))
- Processing Speed - Symbol Digit Modalities Test (SDMT)(12 months post-aSAH)
- Language - Boston Naming Test (BNT)(12 months post-aSAH)
- Verbal Fluency - FAS Test(12 months post-aSAH)
- Executive Functioning - Wisconsin Card Sorting Test (WCST)(12 months post-aSAH)
- Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)(12 months post-aSAH)
- General mental status - Montreal Cognitive Assessment (MoCA)(12 months post-aSAH)
- Functional disability - modified Rankin scale (mRS)(12 months post-aSAH)
- Health-Related Quality of Life (HRQoL, SF-36)(12 months post-aSAH)
研究者
Anna Maria Bombardieri
Assistant Professor
Stanford University