Pilot Testing for Midline Measuring Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Midline Localization
研究概览
简要总结
Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. The investigators have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew Howard III). This is not patented it at this time. There is no company involved in manufacturing (assembly was completed with the help of the hospital's machine shop).
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
- 21 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery
排除标准
- •Patients who are not able to consent
研究组 & 干预措施
Intervention
Patients undergoing ventriculoperitoneal surgery where the midline localizer was used
干预措施: midline localizer (Device)
结局指标
主要结局
Midline Localization
时间窗: Immediate postop, an average of 4 hours
The average distance separating the staple from the lateral edge of the sagittal sinus
次要结局
- Burr Hole Placement(Immediately Post-op, an average of 4 hours)
研究者
Matthew Howard
Professor of Neurosurgery, Head of Department of Neurosurgery at University of Iowa
University of Iowa
