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临床试验/NCT04878653
NCT04878653已完成不适用

Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication

CHRISTUS Health1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年2月25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
51
试验地点
1
主要终点
Patient breath alcohol concentration (BrAC)

研究概览

简要总结

This study is a prospective, controlled study in healthy volunteers all of whom are residents, medical students, faculty physicians, or emergency department nursing and ancillary staff.

详细描述

The breathalyzer, BACtrack S80 Breathalyzer, will be calibrated per manufacturer's recommendations before each reading will be taken. Participants will administer the breathalyzer test on themselves. They will be instructed on how to hold and blow into the breathalyzer machine. Participants will then be instructed to wash his or her hands and an initial breathalyzer reading will be taken and will serve as the control prior to the application of each product. Participants with a result >0 will be excluded from the study. Participants will apply the alcohol-containing product to his or her hands and a second breathalyzer reading will be obtained immediately after application. If the second breathalyzer result is >0, a third breathalyzer reading will be obtained after the product has dried appropriately on the participant's hands (approximately 1 minute after initial application). A minimum of two breathalyzer readings will be obtained from each participant per product application. If the second breathalyzer reading is >0, a third breathalyzer will be obtained from that participant.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals between the ages of 18 and 75
  • Able to verbally consent
  • Residents, medical students, faculty physicians, emergency department nursing and ancillary staff

排除标准

  • Inability to consent
  • Individuals with an initial breathalyzer result greater than 0.000
  • Individuals who have consumed alcohol or used other alcohol-containing products within the last 12 hours

结局指标

主要结局

Patient breath alcohol concentration (BrAC)

时间窗: Through study completion, an estimate of 6 months

1. The BACtrack S80 Breathalyzer was used in this study to measure each individual's breath alcohol concentration (BrAC) to estimate one's blood alcohol concentration (BAC). It is measured as a percentage, i.e. a measurement of 0.040 represents 0.04%. The generally accepted legal standard for alcohol intoxication in the United States is 0.08%. The Outcome Measures include mean readings for each group looking at readings greater than 0%, greater than 0.04%, and greater than 0.08%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordyn Ewbank, DO

Principal Investigator

CHRISTUS Health

研究点 (1)

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