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

NCT04878653 | Completed

• 1 other identifier: 2019-106
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Intoxication Alcohol

Outcome Measures

Primary Outcomes (1)

• Patient breath alcohol concentration (BrAC)

  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%.

  Through study completion, an estimate of 6 months

Interventions

BACtrack S80 Breathalyzer DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Spohn Hospital

Corpus Christi, Texas, 78404, United States

Location

Related Publications (15)

• Klein LR, Cole JB, Driver BE, Battista C, Jelinek R, Martel ML. Unsuspected Critical Illness Among Emergency Department Patients Presenting for Acute Alcohol Intoxication. Ann Emerg Med. 2018 Mar;71(3):279-288. doi: 10.1016/j.annemergmed.2017.07.021. Epub 2017 Aug 24.

  PMID: 28844504 BACKGROUND

• Sebbane M, Claret PG, Jreige R, Dumont R, Lefebvre S, Rubenovitch J, Mercier G, Eledjam JJ, de la Coussaye JE. Breath analyzer screening of emergency department patients suspected of alcohol intoxication. J Emerg Med. 2012 Oct;43(4):747-53. doi: 10.1016/j.jemermed.2011.06.147. Epub 2012 Mar 8.

  PMID: 22406024 BACKGROUND

• Kumar A, Holloway T, Cohn SM, Goodwiler G, Admire JR. The Clinical Evaluation of Alcohol Intoxication Is Inaccurate in Trauma Patients. Cureus. 2018 Feb 14;10(2):e2190. doi: 10.7759/cureus.2190.

  PMID: 29662729 BACKGROUND

• Phillips DP, Brewer KM. The relationship between serious injury and blood alcohol concentration (BAC) in fatal motor vehicle accidents: BAC = 0.01% is associated with significantly more dangerous accidents than BAC = 0.00%. Addiction. 2011 Sep;106(9):1614-22. doi: 10.1111/j.1360-0443.2011.03472.x. Epub 2011 Jun 20.

  PMID: 21689195 BACKGROUND

• Ali SS, Wilson MP, Castillo EM, Witucki P, Simmons TT, Vilke GM. Common hand sanitizer may distort readings of breathalyzer tests in the absence of acute intoxication. Acad Emerg Med. 2013 Feb;20(2):212-5. doi: 10.1111/acem.12073.

  PMID: 23406081 BACKGROUND

• Foglio-Bonda PL, Poggia F, Foglio-Bonda A, Mantovani C, Pattarino F, Giglietta A. Determination of breath alcohol value after using mouthwashes containing ethanol in healthy young adults. Eur Rev Med Pharmacol Sci. 2015;19(14):2562-6.

  PMID: 26221882 BACKGROUND

• Modell JG, Taylor JP, Lee JY. Breath alcohol values following mouthwash use. JAMA. 1993 Dec 22-29;270(24):2955-6.

  PMID: 8254857 BACKGROUND

• Lindsay HA, Hannam JA, Bradfield CN, Mitchell SJ. Breath alcohol of anesthesiologists using alcohol hand gel and the "five moments for hand hygiene" in routine practice. Can J Anaesth. 2016 Aug;63(8):938-44. doi: 10.1007/s12630-016-0666-2. Epub 2016 May 3.

  PMID: 27142004 BACKGROUND

• Strawsine E, Lutmer B. The Effect of Alcohol-Based Hand Sanitizer Vapors on Evidential Breath Alcohol Test Results. J Forensic Sci. 2018 Jul;63(4):1284-1290. doi: 10.1111/1556-4029.13691. Epub 2017 Nov 16.

  PMID: 29143333 BACKGROUND

• Freudenrich C. How breathalyzers work. https://electronics.howstuffworks.com/gadgets/automotive/breathalyzer.htm . Updated October 20, 2000. Accessed February 2, 2019.

  BACKGROUND

• Duke University. The alcohol pharmacology education partnership. https://sites.duke.edu/apep/module-4-alcohol-and-the-breathalyzer-test/. Accessed February 2, 2019.

  BACKGROUND

• Labianca, DA. The flawed nature of the calibration factor in breath-alcohol analysis. J Chemical Edu. 2002;79(10):1237-1240.

  BACKGROUND

• Caravati EM, Anderson KT. Breath alcohol analyzer mistakes methanol poisoning for alcohol intoxication. Ann Emerg Med. 2010 Feb;55(2):198-200. doi: 10.1016/j.annemergmed.2009.07.021. Epub 2009 Oct 14.

  PMID: 19833410 BACKGROUND

• Arndt T, Schrofel S, Gussregen B, Stemmerich K. Inhalation but not transdermal resorption of hand sanitizer ethanol causes positive ethyl glucuronide findings in urine. Forensic Sci Int. 2014 Apr;237:126-30. doi: 10.1016/j.forsciint.2014.02.007. Epub 2014 Feb 18.

  PMID: 24631832 BACKGROUND

• Arndt T, Gruner J, Schrofel S, Stemmerich K. False-positive ethyl glucuronide immunoassay screening caused by a propyl alcohol-based hand sanitizer. Forensic Sci Int. 2012 Nov 30;223(1-3):359-63. doi: 10.1016/j.forsciint.2012.10.024. Epub 2012 Nov 5.

  PMID: 23137849 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking; Alcoholic Intoxication

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jordyn Ewbank, DO

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: May 7, 2021
• Study Start: February 25, 2020
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)