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

Completed

• Conditions: Intoxication Alcohol; Alcohol Drinking

• Registration Number: NCT04878653
• Lead Sponsor: CHRISTUS Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-02-25
• Primary Completion: 2020-10-22
• Study Completion: 2020-10-22
• Study First Submitted: 2020-11-25
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Study First Posted: 2021-05-07
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient breath alcohol concentration (BrAC)	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%.

Trial Locations

Locations (1)

CHRISTUS Spohn Hospital; 🇺🇸 Corpus Christi, Texas, United States