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Alcohol DrinkingNCT04878653

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

An observational study of Alcohol Drinking and Intoxication Alcohol, run by CHRISTUS Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Drinking, Intoxication Alcohol
What is being tested?
BACtrack S80 Breathalyzer
Type of treatment
Medical device
How many people
51 participants
Where
1 siteUnited States
Study dates
25 Feb 2020to 22 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • CHRISTUS Spohn Hospital

    Corpus Christi, Texas, 78404

Other trials in United States

About this study

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.

Read the 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.

Being tested
BACtrack S80 Breathalyzer
Medical subject headings
Alcohol Drinking, Alcoholic Intoxication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BACtrack S80 BreathalyzerDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: Through study completion, an estimate of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start25 Feb 2020
  3. Primary completion22 Oct 2020
  4. Study completion22 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878653
Sponsor's protocol ID
2019-106
Status last verified
May 2021
First submitted
25 Nov 2020
Last updated
7 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Investigator is interested in pursuing future collaborations and grant opportunities.

Publications

  • 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.

    PubMed 28844504

  • 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.

    PubMed 22406024

  • 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.

    PubMed 29662729

  • 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.

    PubMed 21689195

  • 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.

    PubMed 23406081

  • 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.

    PubMed 26221882

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

    PubMed 8254857

  • 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.

    PubMed 27142004

  • 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.

    PubMed 29143333

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

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

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

  • 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.

    PubMed 19833410

  • 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.

    PubMed 24631832

  • 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.

    PubMed 23137849

Questions about this trial

What is this clinical trial studying?

An observational study of Alcohol Drinking and Intoxication Alcohol, run by CHRISTUS Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient breath alcohol concentration (BrAC) (time frame: Through study completion, an estimate of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878653, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.

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