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临床试验/NCT05639036
NCT05639036撤回不适用

Image-guided External Ventricular Drain Placement Trial: a Prospective Randomized-controlled Trial Pilot

Hamilton Health Sciences Corporation1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年6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
撤回
入组人数
40
试验地点
1
主要终点
Study Feasibility

研究概览

简要总结

To determine if use of the Stryker Nav3 image guidance system offers superior results in external ventricular drain (EVD) placement compared to the standard free-hand technique.

详细描述

An external ventricular drain (EVD) is a small tube that is placed into a space in the brain called a ventricle. This is done to drain fluid in the brain that sometimes builds up as a result of surgery or a traumatic brain injury/accident. This is one of most commonly performed procedures in Neurosurgery and is done bedside, not in the operating room. Typically, surgeons will use the "free-hand" technique to place these drains which involves relying on a CT scan, which shows the structures inside of the brain, and their knowledge of the anatomy of the brain and where the EVD should be placed. Image-guidance systems exist which create real time imaging of the patients brain and can act like a GPS to help guide the placement of the EVD in the correct spot. This trial is planned to determine if using the image guidance system does offer improved accuracy in EVD placement, lowering the number of attempts required and therefore the amount of time spent placing the EVD and risk of complications and infections. A pilot study will be done first, using a convenience sample at the Hamilton General Hospital to determine the feasibility of running a larger scale trial in the future.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients requiring EVD placement
  • •patients who can safely and reasonably be randomized to either study arm
  • •patients with available pre-procedural head CT
  • •written/verbal consent obtained

排除标准

  • •patients with very small ventricles/distorted ventricular anatomy from traumatic brain injury (ie it is not reasonable to randomize the patient)
  • •scenarios where the EVD must be inserted immediately and there is not time to obtain consent
  • •scenarios where bedside image guidance system (NAV3) is unavailable
  • •subjects medically or neurologically unstable to obtain pre-EVD CT scan
  • •EVD revisions on ipsilateral side during same admission

研究组 & 干预措施

Control-Free Hand External Ventricular Drain Placement

Active Comparator

This group will receive an external ventricular drain placed using the standard free-hand technique

干预措施: Free Hand External Ventricular Drain Placement (Procedure)

Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System

Experimental

This group will receive an external ventricular drain placed using the assistance of the Stryker NAV3 image guidance system

干预措施: Image Guided External Ventricular Drain Placement Using the NAV3 System (Device)

结局指标

主要结局

Study Feasibility

时间窗: 8 months

Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence)

次要结局

  • Number of attempts(8 months)
  • Accuracy of external ventricular drain (EVD) placement(8 months)
  • Complications(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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