Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 144
- 试验地点
- 12
- 主要终点
- Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle
研究概览
简要总结
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can achieve a more precise placement of ventricular catheters than the standard free-hand placement technique.
详细描述
Free-hand placement of ventricular catheters (VC) is reported to be inaccurate in 10-40%. Furthermore, there is evidence that the quality of VC positioning is correlating with the risk for proximal shunt obstruction. Ultrasound or neuronavigation are used in order to improve to placement. However, they are associated with significant technical efforts and increased time.
In this study a simple instrument assisted by a smart phone application software is used in order to achieve precise placement of ventricular catheters. The results are compared with the standard free-hand procedure. Patients requiring a ventricular catheter are randomized to one of the two treatments. The primary outcome parameter is a qualitative and quantitative assessment of the position of the ventricular catheter on a post-operative image. The evaluation of the primary criteria is performed by a radiologist blinded to the randomization arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring a permanent ventricular catheter for the treatment of CSF (cerebrospinal fluid) - circulation disorder or another disease (ventricular shunt oder Ommaya/Rickham-Reservoir)
- •Frontal occipital horn ratio (FOHR) < 0.5
- •Use of a new puncture channel
- •Frontal access to the ventricles
- •Patient´s informed consent
排除标准
- •Known unevenness of the skull at the entry point
- •Slit ventricles; Frontal and occipital horn width ratio (FOHWR) < 0.05
- •Participation in another clinical trial with interfering endpoints
研究组 & 干预措施
Thomale-Guide
Positioning of ventricular catheter with the Thomale-Guide instrument
干预措施: Thomale-Guide (Device)
Free-hand
Ventricular catheter placement without a guidance (free-hand)
干预措施: Free-hand (Other)
结局指标
主要结局
Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle
时间窗: Within the first 40 days
次要结局
未报告次要终点