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Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?

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ClinicalTrials.gov Identifier: NCT02580318
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania

Brief Summary:
This is a prospective cohort study. The investigators will enroll 50 healthy volunteers. In a safe environment and after signing informed consent, each participant will consume a standardized alcoholic beverage. Using a Breathalyzer, the subjects BAT will be measured. If the subject's BAT is less than 0.10 +/- 0.005, the subject will drink another alcoholic beverage. This process will continue until the subject's BAT is 0.10 +/- 0.005. The number of alcoholic beverages the subject consumes will be monitored by the observers. When the target BAT is reached, the subjects will manipulate the breathalyzer in various ways and measure their BAT again after each manipulation. In a set order, the subjects will manipulate the breathalyzer by using less than the subject's maximal exhalation effort, placing the breathalyzer at the side of the subject's mouth, hyperventilating (10 rapidly (less than 1 second) and successive breaths prior to using the device), repeating breathalyzer 5 minutes and 10 minutes after hyperventilation and then drinking cold water after the breathalyzer at 10 minutes and repeating the breathalyzer after drinking some cold water. Descriptive statistical analyses as well as Pearson's product moment correlation coefficient will be employed to determine if any statistically significant correlation exists for any of the manipulations.

Condition or disease Intervention/treatment Phase
Alcohol Concentration Values Alcohol Intoxication Device: breathalyzer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: all study participants
subjects consumed alcohol to a BrAC of 0.1 and then performed the following manipulations while using the breathalyzer: poor effort, hyperventilation (immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)
Device: breathalyzer



Primary Outcome Measures :
  1. Percent Alcohol Concentration Measured by Breathalyzer [ Time Frame: 20 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers over age 21

Exclusion Criteria:

  • pregnancy
  • alcoholism
  • diabetes
  • kidney/bladder stones
  • kidney disease
  • liver disease
  • stomach ulcer
  • organ transplant patients
  • dialysis patients
  • subjects with alcohol allergies
  • subjects taking the following medications: activated charcoal, ampicillin, carbamazepine, cephaloridine, cloxacillin, methicillin, nitroglycerine, oxacillin, penicillin G, or quinicillin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580318


Locations
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United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania
Investigators
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Principal Investigator: Holly Stankewicz, D.O. St. Luke's University Hospital
Publications of Results:
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Responsible Party: Holly Stankewicz, D.O., Attending physician and faculty emergency medicine resiency, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT02580318    
Other Study ID Numbers: SLHN 2015-28
First Posted: October 20, 2015    Key Record Dates
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Alcoholic Intoxication
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders