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

Not Applicable
Completed
Conditions
Alcohol Intoxication
Alcohol Concentration Values
Interventions
Device: breathalyzer
Registration Number
NCT02580318
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
all study participantsbreathalyzersubjects 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)
Primary Outcome Measures
NameTimeMethod
Percent Alcohol Concentration Measured by Breathalyzer20 minutes
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

St. Luke's Hospital

🇺🇸

Bethlehem, Pennsylvania, United States

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