跳至主要内容
临床试验/NCT04505423
NCT04505423已完成不适用

Evaluation of Outcomes Related to Cerebrospinal Fluid Drains Placed Either With or Without Fluoroscopic Guidance for Aortic Surgery

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
试验地点
1
主要终点
Rate and Severity of Complications Related Associated with CSFD placement

研究概览

简要总结

The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.

详细描述

Patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair are at risk of suffering devastating spinal cord injury (SCI), rendering them with a permanent neurologic deficit, paraplegia, or paraparesis. Despite huge success over the last several decades with the introduction of innovative protective maneuvers, such as the use of cerebrospinal fluid drains (CSFDs), the rate of these complications remains around 5%. Spinal cord perfusion can be compromised during aortic surgery and the intrathecal decompression achieved by CSFDs functions to increase the pressure gradient of blood flow, thereby optimizing spinal cord perfusion during aortic surgery. There are two methods commonly used to place cerebrospinal fluid drains: blind placement and with fluoroscopic guidance. Prior to 2016, CSFDs at UNC hospital were primarily placed without image guidance. However, hospital policy then transitioned to having all CSFDs placed using fluoroscopic guidance. To the investigators' knowledge, there are no reported studies directly comparing clinical outcomes of CSFDs placed by these methods. Given the increased cost and radiation exposure associated with the use of fluoroscopy, a better understanding of comparative outcomes has great potential clinical value. Therefore, the investigators propose to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • CSF drain placed from 2010 to present prior to undergoing aortic surgery

排除标准

  • Patients under 18 years of age
  • Patients undergoing emergency procedures

结局指标

主要结局

Rate and Severity of Complications Related Associated with CSFD placement

时间窗: From admission to discharge, up to 2 weeks

The rate and severity of complications associated with CSFD placement with or without fluoroscopic guidance via a chart review. This will be assessed using quantitative methods such as vital signs and lab-work drawn relating to the procedure as well as qualitative variables through clinical notes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Evaluation of Outcomes Related to Cerebrospinal... | 临床试验