跳至主要内容
临床试验/NCT01973764
NCT01973764终止不适用

Intraventricular Drain Insertion:Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System. A Prospective Randomised Clinical Trial Study.

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
1
主要终点
The correct ventricular catheter position (on post op CT) after single ventricular puncture.

研究概览

简要总结

Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is needed. Currently the "landmark-based" placement of intraventricular catheters is the gold standard. However it is known that more than 60% of the catheters are not accurately placed in accordance with "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may be required. In this study, the investigators aim to investigate prospectively whether ultrasound guidance leads to a lower number of incorrect catheter placements, and whether this guidance consequently decreases the number of punctures.

详细描述

Background

Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed. Currently the "landmark-based" placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may has to be done.

Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed.Currently the "landmark-based" placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing "landmark-based" procedures. When the catheter is not placed accurately multiple punctures may be required. Incorrectly placed intraventricular catheters may lead to undesirable side effects like catheter dysfunction,in which case a correction of the catheter position or a even a new puncture will be required. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain injuries. In this study, the investigators will prospectively investigate whether ultrasound guidance increases the number of well-placed ventricular catheters and reduces the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the lateral ventricle (ipsilateral to the burrhole) anterior of the foramen of Monro. Catheter tip position will be assessed by cranial computer tomography after the operation. The CT scans will be evaluated by an independent expert rater, blinded for the procedure type. These incorrectly placed intraventricular catheters may lead to undesirable side effects, like catheter dysfunction wherefore a correction of the catheter position or a even a new puncture has to be done. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain damages.

In this study, the investigators will prospectively investigate if ultrasound guidance may raise the number of well placed ventricular catheters and may reduce the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the ipsilateral lateral ventricle (to the burrhole) anterior of the foramen of monroi and will be assessed by cranial computer tomography after operation. The CT Scans will be evaluated by an independent expert rater, blinded for the procedure type.

Objective

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

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

  • •Age >/= 18 years
  • •Intraventricular catheter insertion or/and intraventricular pressure measurement indicated
  • •Written informed consent

排除标准

  • •Age < 18 years
  • •previous ventricular punction < 4 weeks
  • •bedside puncture indicated

研究组 & 干预措施

Ultrasound guided arm

Other

干预措施: Ultrasound guided ventricular drain insertion (Procedure)

Landmark-based arm

Other

干预措施: landmark-based ventricular drain insertion (Procedure)

结局指标

主要结局

The correct ventricular catheter position (on post op CT) after single ventricular puncture.

时间窗: 48 h after initial operation

次要结局

  • Number of catheter changes(at hospital discharge, expected to be after 10 days)
  • Number of infections(at hospital discharge, expected to be after 10 days)
  • Number of days in clinic(at hospital discharge, expected to be after 10 days)
  • Number of ventricular punctures("at the end of the operation, expected to be after 1 hour")
  • Number of patients with intracerebral hemorrhage(24 h after initial operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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