跳至主要内容
临床试验/NCT01426217
NCT01426217已完成不适用

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

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 594 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
594
试验地点
2
主要终点
Presence of Bacterial IV Stopcock Lumen Contamination

研究概览

简要总结

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.

详细描述

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 (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Presence of Bacterial IV Stopcock Lumen Contamination

时间窗: 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

次要结局

  • Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination(Until positive, up to 5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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