此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Reduction in IV Associated Contamination

2018年9月20日 更新者:Dartmouth-Hitchcock Medical Center

Reduction in Intraoperative Lumen Contamination of Standard 3-Way Open Lumen Stopcock Sets Through Use of a Novel, Passive Bundle

The purpose of this study is to investigate whether implementing a novel syringe and IV stopcock cap system impregnated with alcohol will reduce IV catheter bacterial contamination and infections in patients.

研究概览

详细说明

Bacterial contamination of patient intravenous stopcock sets is a common intraoperative event associated with increased patient mortality, possibly via an infectious mechanism. The most common type of intravenous tubing used in operating rooms is the open lumen stopcock set which lacks a barrier between the environment and intraluminal space, and thus the intravascular space of the patient. The stopcock connector can be easily contaminated by provider hands due to improper handling of the device and/or contaminated by soiled syringe tips subsequently connected to the device. Further, the stopcock connector is often left uncapped by the provider and directly exposed to the environment. Thus, common breaches in intraoperative aseptic practice of healthcare providers can lead to bacterial contamination of the endoluminal space of the open lumen device. The primary aim of the current study is to assess the efficacy of a passive bundle designed to decrease intravenous stopcock and tubing intraluminal bacterial contamination. This passive bundle includes two novel interventions, a DOCit station and HubScrub caps. The HubScrub is designed to clean the needleless connectors and open lumen stopcock systems. The DOCit station is designed to simultaneously clean the interior and exterior of needle-less luer connectors of syringes with isopropyl alcohol while also providing a method of storage and organization of multiple syringes. The investigators hypothesize that the application of this passive bundle to the standard open lumen system commonly employed by anesthesia providers in the operating room will significantly reduce bacterial contamination of standard 3-way open lumen stopcock sets and improve patient safety.

研究类型

介入性

注册 (实际的)

594

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth-Hitchcock Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult patient undergoing surgery or procedure in operating room
  • Undergoing general anesthesia

Exclusion Criteria:

  • Children (age < 18 years)
  • Lack of intravenous access
  • failure of anesthesia provider to complete training on experimental device

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:Control
Control arm using standard of care operating room procedures and equipment
实验性的:Problem Solving Innovations (PSI) Experimental
Implementation of the passive bundle including HubScrub and DocIt
Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.
其他名称:
  • PSI Medical HubScrub
  • PSI Medical DocIt

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Presence of Bacterial IV Stopcock Lumen Contamination
大体时间:48 hours
The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed
48 hours

次要结果测量

结果测量
措施说明
大体时间
Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination
大体时间:Until positive, up to 5 days
Open lumen ports were removed from the patient; sent directly to the anesthesiology microbiology laboratory; connected by the same clinical laboratory scientist to sterile catheters using sterile, aseptic technique; and injected directly into a BacT/Alert 3D system (bioMérieux Inc., Durham, NC) with 2 mL of sterile saline per port. BacT/Alert is a blood culture system that automatically monitors bacterial growth using colorimetry; a sensor inserted at the bottom of the bottle changes color on detecting the carbon dioxide produced by the growth of the bacteria. Catheters were then removed, and the bottles were directly incubated in the BacT/Alert system for 5 days or until positive. Once positive, the liquid in the bottle was examined to identify the organism.
Until positive, up to 5 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Bryan S Brindeiro, MD、Dartmouth-Hitchcock Medical Center
  • 研究主任:Randy W Loftus, MD、Dartmouth-Hitchcock Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年8月1日

初级完成 (实际的)

2011年11月1日

研究完成 (实际的)

2011年11月1日

研究注册日期

首次提交

2011年8月29日

首先提交符合 QC 标准的

2011年8月30日

首次发布 (估计)

2011年8月31日

研究记录更新

最后更新发布 (实际的)

2018年10月18日

上次提交的符合 QC 标准的更新

2018年9月20日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 22743

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.

术后感染的临床试验

3
订阅