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

Sponsor
CHRISTUS Health (Other)
Overall Status
Completed
CT.gov ID
NCT04878653
Collaborator
(none)
51
1
7.9
6.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BACtrack S80 Breathalyzer

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 Design

Study Type:
Observational
Actual Enrollment :
51 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication
Actual Study Start Date :
Feb 25, 2020
Actual Primary Completion Date :
Oct 22, 2020
Actual Study Completion Date :
Oct 22, 2020

Outcome Measures

Primary Outcome Measures

  1. 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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRISTUS Spohn Hospital Corpus Christi Texas United States 78404

Sponsors and Collaborators

  • CHRISTUS Health

Investigators

  • Principal Investigator: Jordyn Ewbank, DO, CHRISTUS Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jordyn Ewbank, DO, Principal Investigator, CHRISTUS Health
ClinicalTrials.gov Identifier:
NCT04878653
Other Study ID Numbers:
  • 2019-106
First Posted:
May 7, 2021
Last Update Posted:
May 7, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 7, 2021