跳至主要内容
临床试验/NCT04039906
NCT04039906已完成不适用

A Single-institutional Study to Assess the Impact of ANDY(Automatic Needle Destroyer) to the Medical Staffs in Terms of Working Efficiency Assessed by Working Time and Satisfaction Assessed by Usability and Safety Using SUS Score and Survey

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 129 人开始时间: 2019年9月2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
129
试验地点
2
主要终点
Time Efficiency: Comparing the time required to remove the needle from syringe for assessing change in time between using automated needle processing system or not

研究概览

简要总结

Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety when using ANDY(Automatic Needle Destroyer). Install ANDY(Automatic Needle Destroyer) in the ER, and evaluate the system by comparing the efficiency of the work, usability, actual decrease ratio of needlestick injury between using the automated needle processing system and not using it.

详细描述

  1. Background The most frequent occupational injury is exposure to blood and fluid by needlestick injury. Needlestick injuries can result in serious infections if appropriate infection control measures are not taken promptly.

Since the use of safety devices are not popularly used, the needle and syringe are mostly taken into pieces by physical ways. There are some cases that the needle and syringe is not separated, and the entire syringe can be put directly into the waste container. There is also a problem that it takes a lot of time and efforts to remove needles from syringes. In addition, the existing safety mechanism is physical methods such as pulling out the needle, damaging or cutting the needle, or using heat to the needle, or melting it by using chemicals. It is a semi-manual since you have to wait holding the syringe during the process, and it is inconvenient to use considering a busy medical environment.

Therefore, we developed ANDY(Automatic Needle Destroyer) that can be introduced at a convenient and reasonable cost, and try to objectively evaluate the utility of ANDY in a clinical environment. 2. Purpose The purpose of this study is to Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety of the system. 3. Design : RCT (randomized controlled trial) 4. Setting: EMERGENCY CENTER at the Samsung Medical Center 5. Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box) 6. Intervention :

6-1) 1st Week : Removal of needle with existing method

  • Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
  • Identify the number of syringes processed by existing method.
  • Do survey after 1st week

6-2) 2nd week: Prepare for using ANDYs

  • Provide clinicians with instruction how to use ANDY
  • Install 10 ANDYs in the ER.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • medical staff of the ER
  • adult ER medical staff over 19 years of age
  • A subject who voluntarily agrees and signs

排除标准

  • A subject who did not agree with this study

结局指标

主要结局

Time Efficiency: Comparing the time required to remove the needle from syringe for assessing change in time between using automated needle processing system or not

时间窗: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)

\- Comparison of the required time(second) to remove the needle between using the automated needle processing system and not using it.

次要结局

  • Safety: Comparing the number of accidents of the needlestick injuries between using automated needle processing system or not([1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system))
  • Usability: Comparing the SUS score for assessing the change in usability between using automated needle processing system or not([1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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