A Head-to-head Comparison of Catheter Thread Between Two Epidural Kit Vendors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced a Successful Thread at First Pass
研究概览
简要总结
The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different epidural pain management kits vendors
详细描述
The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different pain management kits. In order to improve patient care, if there is a difference in the time to thread epidurals with one kit over the other, we would like to use the kit with decreased time to thread in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women in labor
排除标准
- 未提供
研究组 & 干预措施
Arrow Catheter Kit.
Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.
干预措施: Arrow Catheter Kit. (Device)
B.Braun Catheter Kit
Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.
干预措施: B.Braun Catheter Kit (Device)
结局指标
主要结局
Number of Participants Who Experienced a Successful Thread at First Pass
时间窗: within 60min of first attempt at placement
A thread is considered successful at first pass if there were no minor or major manipulations required.
次要结局
- Incidence of Epidural Intravascular Cannulations(within 60min of first attempt at placement)
- Incidence of Paresthesia(within 60min of first attempt at placement)
- Time to Thread Epidural Catheter(within 60min of first attempt at placement)
- Incidence of Unintended Dural Punctures(within 60min of first attempt at placement)
- Epidural Needle Manipulations Needed to Successfully Advance(within 60min of first attempt at placement)
研究者
Carlo Pancaro
Associate Professor of Anesthesiology
University of Michigan