跳至主要内容
临床试验/NCT04406220
NCT04406220已完成不适用

The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial

Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Time to complete the running course

研究概览

简要总结

In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly,

The primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed.

Participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course.

The primary endpoint is the time taken to complete the course.

The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation.

The ethical committee judged the study protocol exempt from extensive review.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Healthcare workers aged 18 years or older.

排除标准

  • Inability to run on clogs.

结局指标

主要结局

Time to complete the running course

时间窗: Follow-up until 60 minutes.

The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.

次要结局

  • Time to complete the running course for specific subgroups: By gender, job function, level of fitness.(Follow-up until 60 minutes.)
  • Adverse events(Follow-up until 60 minutes.)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

H.J.S. de Grooth, MD

Coordinating investigator

Amsterdam UMC, location VUmc

研究点 (2)

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