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

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

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 minutes

Population: number of participants that completed breath alcohol content are reported.

Outcome measures

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

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place