Trial Outcomes & Findings for Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings? (NCT NCT02580318)
NCT ID: NCT02580318
Last Updated: 2017-09-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
20 minutes
Results posted on
2017-09-15
Participant Flow
54 participants.
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
Poor Effort
|
53
|
|
Overall Study
Hyperventilation (Immediate)
|
54
|
|
Overall Study
Hyperventilation (5 Minutes)
|
54
|
|
Overall Study
Hyperventilation (10 Minutes)
|
54
|
|
Overall Study
Drinking Water (Immediate)
|
51
|
|
Overall Study
Drinking Water (5 Minutes)
|
54
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=54 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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: number of participants that completed breath alcohol content are reported.
Outcome measures
| Measure |
All Study Participants
n=54 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)
|
|---|---|
|
Percent Alcohol Concentration Measured by Breathalyzer
poor effort
|
0.099 percent Breathalyzed alcohol content
Standard Deviation .010
|
|
Percent Alcohol Concentration Measured by Breathalyzer
hyperventilation (immediate)
|
0.086 percent Breathalyzed alcohol content
Standard Deviation 0.011
|
|
Percent Alcohol Concentration Measured by Breathalyzer
hyperventilation (5 minutes)
|
0.099 percent Breathalyzed alcohol content
Standard Deviation 0.009
|
|
Percent Alcohol Concentration Measured by Breathalyzer
hyperventilation (10minutes)
|
0.099 percent Breathalyzed alcohol content
Standard Deviation 0.011
|
|
Percent Alcohol Concentration Measured by Breathalyzer
drinking water(immediate)
|
0.084 percent Breathalyzed alcohol content
Standard Deviation 0.011
|
|
Percent Alcohol Concentration Measured by Breathalyzer
drinking water (5 minutes)
|
0.096 percent Breathalyzed alcohol content
Standard Deviation 0.013
|
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants
n=54 participants at risk
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)
|
|---|---|
|
Gastrointestinal disorders
vomiting
|
3.7%
2/54 • 12 hours
|
|
Nervous system disorders
vertigo
|
3.7%
2/54 • 12 hours
|
Additional Information
Holly Stankewicz, D.O.
St. Luke's University Health Network
Phone: 610-360-2725
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place