跳至主要内容
临床试验/NCT00231374
NCT00231374撤回不适用

In Vivo Analysis of Intradural Pressure Variation With Patient Positioning

Emory University2 个研究点 分布在 1 个国家开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.

研究概览

简要总结

This is a study looking at pressure changes in the fluid that surrounds the spine when a person is positioned in 2-3 different ways.

详细描述

Volunteers who need a myelogram of their spine as part of their routine medical care are being asked to be in this study. A myelogram is an imaging study with x-rays after an agent is put into the spine that shows spinal fluid on the x-ray. It requires insertion of a needle into the cerebrospinal fluid (CSF) inside the spine. CSF is a bodily fluid that bathes the brain, spinal cord, and nerve roots. This study is being conducted to measure CSF pressure changes with different patient positioning.

We are motivated to do this research study to better treat patients who develop a spinal fluid leak during a myelogram or other spine procedure. The tissue that holds the cerebrospinal fluid (CSF) is called the dura. During surgery or other procedures, the dura can develop a tear. Dural tears can result in a leakage of CSF. CSF leaks are a recognized complication of spinal surgery. Currently, there is no evidence on whether or not a specific postoperative spine position is beneficial, especially for cervical (neck spine) CSF leaks. The process of dural healing after a dural tear is influenced by CSF pressure. High CSF pressure may inhibit dural healing. We want to find the patient position (sitting, lying down, or reclining) that reduces the CSF pressure the most. To do this, we want to attach a pressure monitor to the needle that is normally placed in the spine for a myelogram and measure the CSF pressure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Need a lumbar or cervical myelogram as part of routine care.

排除标准

  • Not needing a myelogram in the cervical or lumbar spine.

结局指标

主要结局

CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.

CSF pressure measurements on 5 patients having a lumbar myelogram in 2 positions.

次要结局

  • Safety measurements of one position over another.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

S. Tim Yoon, M.D.

Associate Professor

Emory University

研究点 (2)

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