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临床试验/NCT04806776
NCT04806776已完成不适用

Central Venous Catheter Dressing Change and Bacterial Colonization in Pediatric Intensive Care Unit

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2021年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
280
试验地点
1
主要终点
Incidence of Bacterial colonization in the skin under dressing

研究概览

简要总结

This study is non-inferiority trial design.The relationship between whether dressing change 24hrs after CVC (central venous catheter) catheterization and bacterial colonization of the skin.

详细描述

Central venous catheter (CVC) was punctured directly through jugular vein, subclavian vein and femoral vein, and its tip is located in superior vena cava or inferior vena cava. CVC is widely used in ICU because of its kinds of advantages. However, CVC, as an invasive puncture method, may bring more complications. The incidence of central line associated bloodstream infection (CLABSI) was 1.33-31.6/1000 catheterization day , and the death rate due to CVC associated bloodstream infection is 3-5% . Therefore, various organizations have formulated guidelines for the prevention of CLABSI and best evidence summary . From October 2019 to April 2020, taking the children's hospital of Fudan University as the leading unit, PICU of children's Hospital Affiliated to Zhejiang University, Anhui children's Hospital, Xiamen children's Hospital, Shenzhen Children's Hospital and Guangzhou Women's and Children's medical center as the cooperation units, carried out children's central venous catheterization Multi center research on best practices of management and maintenance. It was found that changing dressings 24 hours after catheterization may increase the incidence of MARSI, and repeatedly exposing dressings may also increase the incidence of CLABSI. The research team returned to the original evidence and consulted the guidelines. It was found that: under the premise of achieving the maximum aseptic catheterization, the guidelines issued by various institutions did not mention that the application should be replaced 24 hours after catheterization; however, the evidence was mentioned in the evidence summary, but there was no support from the relevant original literature. Therefore, it is worth discussing whether children need to change dressings 24 hours after catheterization. This study is non-inferiority trial design.

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
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • CVC catheter was placed in the research site (including the operating room and PICU);
  • only one CVC catheter was placed during the research time

排除标准

  • catheter was inserted from another hospital and in emergency;
  • the tip of CVC catheter was not in the upper and lower vena cava;
  • children had history of CLABSI before the study

结局指标

主要结局

Incidence of Bacterial colonization in the skin under dressing

时间窗: 7days or 8days of central venous catheter insertion

incidence of bacterial colonization in the skin under dressing :7days or 8days after insertion,when nurse change the CVC dressing,The researchers used 4 normal saline cotton swabs to wipe the skin under the dressing. Taking the puncture point as the center, 4 cotton swabs wipes 4 points in the northwest, northeast, Southeast and northeast direction 1cm away from the puncture point,separately. Samples were inoculated on Petri dishes respectively.The type and quantity of bacteria will be reported by the Laboratory. The colony number above 20 CFU(colony-forming units) / cm2 means Bacterial colonization occurred.

次要结局

  • Incidence of Medical adhesive-related skin injury(MARSI)(from cvc insertion to 7days or 8days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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