Alcohol Concentration Values, Alcohol Intoxication
Conditions
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.
Interventions
DEVICEbreathalyzer
Sponsors
St. Luke's Hospital and Health Network, Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Alcohol Concentration Measured by Breathalyzer | 20 minutes |
Countries
United States
Participant flow
Pre-assignment details
54 participants.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants participants drank beer to a BrAC level of 0.1 and then were instructed to do the following manipulations: poor effort, hyperventilation(immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes) | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 54 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 54 participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 32 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 4 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Percent Alcohol Concentration Measured by Breathalyzer
Time frame: 20 minutes
Population: number of participants that completed breath alcohol content are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Percent Alcohol Concentration Measured by Breathalyzer | poor effort | 0.099 percent Breathalyzed alcohol content | Standard Deviation 0.01 |
| All Study Participants | Percent Alcohol Concentration Measured by Breathalyzer | hyperventilation (immediate) | 0.086 percent Breathalyzed alcohol content | Standard Deviation 0.011 |
| All Study Participants | Percent Alcohol Concentration Measured by Breathalyzer | hyperventilation (5 minutes) | 0.099 percent Breathalyzed alcohol content | Standard Deviation 0.009 |
| All Study Participants | Percent Alcohol Concentration Measured by Breathalyzer | hyperventilation (10minutes) | 0.099 percent Breathalyzed alcohol content | Standard Deviation 0.011 |
| All Study Participants | Percent Alcohol Concentration Measured by Breathalyzer | drinking water(immediate) | 0.084 percent Breathalyzed alcohol content | Standard Deviation 0.011 |
| All Study Participants | Percent Alcohol Concentration Measured by Breathalyzer | drinking water (5 minutes) | 0.096 percent Breathalyzed alcohol content | Standard Deviation 0.013 |
Comparison: this p value is calculated for poor effortp-value: <0.0001t-test, 2 sided
Comparison: p value calculated for hyperventilation (immediate)p-value: <0.0001t-test, 2 sided
Comparison: p value calculated for hyperventilation (after 5 minutes)p-value: <0.0001t-test, 2 sided
Comparison: p value calculated for hyperventilation (after 10 minutes)p-value: <0.0001t-test, 2 sided
Comparison: p value calculated for drinking water (immediate)p-value: <0.0001t-test, 2 sided
Comparison: p value calculated for drinking water (5 minutes)p-value: <0.0001t-test, 2 sided