Bacterial Colonization After Tunneling in Femoral Perineural Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- incidence of femoral perineural catheter colonization
研究概览
简要总结
Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis.
Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters.
Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome).
Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter
排除标准
- •Age under 18 years
- •Local nerve pathology
- •Refusal to regional anaesthesia
- •Major psychological disorder
- •Major cardiac conduction disease
- •Infection at the puncture site
研究组 & 干预措施
Control
femoral tunnelized perineural catheter
干预措施: tunnelized perineural catheter (Procedure)
结局指标
主要结局
incidence of femoral perineural catheter colonization
时间窗: between 24 hours and 72 hours
次要结局
未报告次要终点