CompuFlo CathCheck; Using Pulse Wave Analysis Versus the Epidurogram for Determining Epidural Catheter Location, A Crossover Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CompuFlo's Success
研究概览
简要总结
The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patients (age 18-99 years old) undergoing epidural placement for an operative procedure will be eligible for participation in this study.
排除标准
- •All patients unable to receive or who refuse placement of epidural will be excluded
- •patients who are unable to consent
- •non-English speakers, pregnant individuals)
- •Individuals with known or who have an allergic reaction to bupivacaine
研究组 & 干预措施
Experimental group
干预措施: 3 methods intervention (Device)
结局指标
主要结局
CompuFlo's Success
时间窗: baseline
The measure is a binary outcome: the epidural catheter is in the epidural space or not. Each modality assessed will either conclude positive (in the correct space) no negative (notnint he correct space) There is no "value". The tools used for the assessment is actually what is being studied, compuflo, meniscus test, physical exam and epidurogram.
次要结局
未报告次要终点