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临床试验/NCT00754754
NCT00754754已完成不适用

Brain Retraction Monitoring Sensor

Vanderbilt University6 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2008年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
6
主要终点
Duration and intensity of brain retraction pressure

研究概览

简要总结

The purpose of this study is to utilize a sensor incorporated into a brain retractor blade to monitor electrical activity and pressure applied to the brain during retraction required for the selected skull base operations. The overall goal of the study is to develop a protocol and guidelines to prevent the development of brain retraction injury during neurosurgical procedures requiring significant retraction.

详细描述

During neurosurgical operations for aneurysms, tumors, or other lesions located in the skull base, the surgeon must employ retracting devices in order to displace one or more lobes of the brain enough to gain adequate surgical exposure. These retractors are adjusted by hand to optimize exposure. It is often difficult for the surgeon to gauge the amount of pressure actually applied to the brain during such placement of the retractor. Moreover, it is also possible to position the blade of the retractor inadvertently such that a focal pressure point occurs at the tip of the retractor blade against the brain. Thus, injury to the brain can occur as a result of brain retraction when either the force applied is excessive or when the pressure is not adequately distributed to a large enough area of brain. This injury is thought to be the result of ischemia (inadequate blood flow) caused by the retraction, local trauma, or a combination of both. It has been estimated that this type of brain retraction injury occurs in approximately 10% of major cranial base tumor procedures or 5% of intracranial aneurysm surgeries. The specific aim of this research is to identify changes in electrical activity of brain tissue subjected to necessary retraction during neurosurgical procedures that may give forewarning of imminent brain retraction injury. It is anticipated that this information will permit development of guidelines that will enable the neurosurgeon to take steps to minimize such injury, i.e., by temporarily releasing or otherwise modifying the brain retraction. Cerebral electrical activity, together with the amount of retraction pressure being applied, will be recorded directly from the tissue at risk by means of a silastic electrode grid containing a pressure monitor placed on the surface of the cerebral cortex underneath the retractor blade.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • A patient must be scheduled to undergo skull base surgery requiring significant brain retraction
  • Informed Consent

排除标准

  • None, other than patients in whom major surgical complications are encountered that are unrelated to brain retraction may be excluded from subsequent data analysis

研究组 & 干预措施

Brain Retraction Monitoring Sensor

Experimental

干预措施: Brain Retraction Monitoring Sensor (Procedure)

结局指标

主要结局

Duration and intensity of brain retraction pressure

时间窗: Intraoperative

次要结局

  • Local Electrocorticography (ECoG)(Postoperative)
  • Radiographic retraction injury(Postoperative)
  • Clinical deficits(Postoperative)
  • Cortical DC potential(Postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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