Bacterial Colonization After Tunneling in Femoral Perineural Catheters (Tunnelized KT)
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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Rouen、法国、76031
- Rouen University Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
Inclusion Criteria:
- Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter
Exclusion Criteria:
- Age under 18 years
- Local nerve pathology
- Refusal to regional anaesthesia
- Major psychological disorder
- Major cardiac conduction disease
- Infection at the puncture site
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:控制
|
|
|
实验性的:femoral tunnelized perineural catheter
|
the catheter will be tunneled 2-3 cm subcutaneously.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
incidence of femoral perineural catheter colonization
大体时间:between 24 hours and 72 hours
|
between 24 hours and 72 hours
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.