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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04878653
Enrollment
51
Registered
2021-05-07
Start date
2020-02-25
Completion date
2020-10-22
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Intoxication Alcohol

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.

Interventions

DEVICEBACtrack S80 Breathalyzer

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.

Sponsors

CHRISTUS Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient breath alcohol concentration (BrAC)Through study completion, an estimate of 6 months1\. 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%.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026