N/A
N=54
Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
Alcohol Concentration Values · Alcohol Intoxication
Bottom Line
View on ClinicalTrials.gov: NCT02580318 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Percent Alcohol Concentration Measured by Breathalyzer — 0.099; 0.086; 0.099; 0.099 percent Breathalyzed alcohol content — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- breathalyzer (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Alcohol Concentration Measured by Breathalyzer |
0.099; 0.086; 0.099; 0.099; 0.084; 0.096 | <0.0001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02580318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.