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