Clinical trial NCT04878653: Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication
Official title: Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Drinking
Intoxication Alcohol
Lead sponsor: CHRISTUS Health
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A maximum of 50 healthy individuals between the ages of 18 and 75 who are willing to participate and able to verbally consent for this study. Volunteers will include residents, medical students, faculty physicians, or emergency department nursing and ancillary staff. Demographics collected for each participant will include age and gender.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient breath alcohol concentration (BrAC)
timeFrame: Through study completion, an estimate of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: CHRISTUS Spohn Hospital
state: Texas
Study officials:
affiliation: CHRISTUS Health
name: Jordyn Ewbank, DO
role: PRINCIPAL_INVESTIGATOR
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