Ultrasound (US) Guided External Ventricular Catheter Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Average number of passes needed to place the catheter in each subject.
研究概览
简要总结
To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.
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
- •Decision made to perform the procedure by the primary consultant
- •Age 18 or older
- •Neuro ICU stay
- •Newly diagnosed hydrocephalus
- •Has a recent CT within the past 24 hrs
- •Normal platelets and coagulation profile
- •No active infection or currently on antibiotics
- •The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging
排除标准
- •Not in Neuro ICU setting
- •Previous placement of a ventricular catheter
- •More than 50 percent of the fluid compartment is filled with blood by CT scan
- •Time to include in the trial prohibited by clinical personnel
研究组 & 干预措施
Catheter placement with Solopass system
The Solopass US system will be used during catheter placement procedure to guide the placement of the catheter.
干预措施: Catheter Placement with Solopass System (Device)
结局指标
主要结局
Average number of passes needed to place the catheter in each subject.
时间窗: 0 minutes
Measured by the number of passes needed to place the catheter. If the first attempt fails, another US sweep will be performed, and another attempt will be performed. If that fails, then the procedure will be aborted.
次要结局
- Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system(up to 7 days)
研究者
Chris Zacko
Chris Zacko, MD Professor and Vice Chair for Quality, Department of Neurosurgery
Milton S. Hershey Medical Center