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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878653
• Other study ID #: 2019-106
• Status: Completed
• Start date: February 25, 2020
• Est. completion date: October 22, 2020

Study information

• Verified date: May 2021
• Source: CHRISTUS Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 22, 2020
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholic Intoxication
• Intoxication Alcohol

Intervention

Device:
• BACtrack 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.

Locations

Country	Name	City	State
United States	CHRISTUS Spohn Hospital	Corpus Christi	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CHRISTUS Health

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

Arndt T, Grüner J, Schröfel 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. — View Citation

Arndt T, Schröfel S, Güssregen 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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

Modell JG, Taylor JP, Lee JY. Breath alcohol values following mouthwash use. JAMA. 1993 Dec 22-29;270(24):2955-6. Erratum in: JAMA 1994 Feb 16;271(7):505. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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