跳至主要内容
临床试验/NCT06665009
NCT06665009招募中不适用

Utilization and Evaluation of Ampoule Peel Device

Chih-Cheng Wu1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
16
试验地点
1
主要终点
events of injury

研究概览

简要总结

Nurses frequently handle ampoule bottles in their daily work, and due to the fragile nature of these glass bottles, manual opening often leads to hand injuries. According to studies, a high proportion of occupational injuries among nurses are caused by handling ampoule bottles, especially hand lacerations. These injuries not only affect work efficiency but also increase medical risks. Therefore, to improve safety and reduce occupational injuries, this study aims to evaluate a patented ampoule peeling device, which has also won the National Innovation Award, to assess whether it can enhance the safety and satisfaction of nurses during their work.

详细描述

The primary objective of this study is to evaluate the ampoule peeling device in terms of safety, ease of use, time efficiency, difficulty of operation, and user satisfaction among nurses when opening ampoule bottles of different capacities. A key focus is to determine whether the device can reduce the risk of hand injuries and improve work efficiency.

Study Design and Procedures:

The study will be conducted in three phases:

  1. Phase 1 (Experimental Study):

In a quiet and controlled environment, nurses will manually and using the ampoule peeling device, open different sizes of ampoule bottles (1ml, 2ml, 5ml, 10ml). Each participant will record the time required, safety, difficulty, success rate, and any incidents of hand injuries during the process. After completing both methods, participants will fill out subjective evaluation forms to assess their satisfaction with each method. 2. Phase 2 (Observational Study):

研究设计

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

入排标准

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

入选标准

  • 16 nursing staff members from W72, W75, and the Department of Anesthesiology, who passed the preliminary tests and are willing to continue to the subsequent phases

排除标准

  • Nursing staff unwilling to participate, unable to manually break ampoules, experiencing difficulty during the preparatory phase, or deciding to discontinue or withdraw during the process.

结局指标

主要结局

events of injury

时间窗: through study completion, an average of 1 year

events times and sites of injury from different volumes of ampoules

time efficiency

时间窗: through study completion, an average of 1 year

time spent needed to open ampules manually or by ampoule openers by seconds

subjective estimation of safety

时间窗: through study completion, an average of 1 year

subjective estimation of safety by a scale out of a maximum score of 5, with 1 stands for "strongly disagree" and 5 stands for "strongly agree".

次要结局

  • ease of use(through study completion, an average of 1 year)
  • difficulty of operation(through study completion, an average of 1 year)
  • user satisfaction(through study completion, an average of 1 year)

研究者

发起方
Chih-Cheng Wu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chih-Cheng Wu

head, Department of Pain Management, Taichung Veterans General hospital

Taichung Veterans General Hospital

研究点 (1)

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