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临床试验/NCT03391960
NCT03391960已完成不适用

A Compliance Improvement Project to Reduce Central Line Associated Blood Stream Infection (CLABSI) Using a Passive Disinfection Device in an Adult Oncological Hospital in Brazil

Solventum US LLC2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2018年4月1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
165
试验地点
2
主要终点
Disinfecting Barrier Cap Compliance

研究概览

简要总结

Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.

The purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.

The compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.

详细描述

Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.

The purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.

Compliance is defined as following the protocol for disinfection of the catheter port. In the pre-intervention period, the disinfection protocol will utilize existing institution scrub-the-hub method. Compliance in the pre-intervention period will be determined by survey.

After the pre-intervention period is complete, passive disinfecting devices (caps) will be implemented hospital-wide for any adult patient using CVC ports.

In the intervention period, the disinfection protocol consists of using the disinfecting barrier cap on every needless connector (catheter port) used for accessing CVC IV lines per protocol. Compliance will be measured using observations, according to a schedule to ensure the absence of a shift bias. Observations will contain the number of needless connectors on CVCs with, and the number of needleless connectors without, disinfecting barrier caps attached.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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 patients admitted to the participant oncologic hospital
  • Adult patients in the assigned intervention units during the seven month intervention period who require needleless connectors for CVC IV tubing access.

排除标准

  • Adult patients admitted to the participant oncologic hospital during the seven month intervention period that do not require needleless connectors for CVC IV access during their hospital stay.

结局指标

主要结局

Disinfecting Barrier Cap Compliance

时间窗: 6-month prospective period

Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage.

Scrub the Hub Protocol Compliance

时间窗: 6-month retrospective period

Compliance with Scrub the hub protocol Data collected retrospectively by survey

次要结局

  • CLABSI Rate(6-month retrospective period and 6-month prospective period)
  • Catheter-associated Urinary Tract Infection (CAUTI) Rate(6 months pre-intervention and 6 months post intervention)
  • Ventilator-associated Pneumonia (VAP) Rate(6-month retrospective period and 6-month prospective period)
  • MBI-Related CLABSI Rate(6-month retrospective period and 6-month prospective period)
  • Non MBI-related CLABSI Rate(6-month retrospective period and 6-month prospective period)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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