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

NCT ID: NCT04878653

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-25

Study Completion Date

2020-10-22

Brief Summary

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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

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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.

Conditions

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Alcohol Drinking Intoxication Alcohol

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CHRISTUS Health

OTHER

Sponsor Role lead

Responsible Party

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Jordyn Ewbank, DO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordyn Ewbank, DO

Role: PRINCIPAL_INVESTIGATOR

CHRISTUS Health

Locations

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CHRISTUS Spohn Hospital

Corpus Christi, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28844504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22406024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29662729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21689195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23406081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26221882 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8254857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27142004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29143333 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 19833410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24631832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23137849 (View on PubMed)

Other Identifiers

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2019-106

Identifier Type: -

Identifier Source: org_study_id

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