Trial Outcomes & Findings for Breathalyzer Validation Study (NCT NCT04086576)
NCT ID: NCT04086576
Last Updated: 2020-10-20
Results Overview
Difference in Breath Alcohol Concentration (BrAC) from police-grade (Intoxilyzer 240) and consumer smartphone-paired breath testing devices relative to Blood Alcohol Concentration (BAC) measured from blood draw after tertiary dose of alcohol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
8 Hours
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
Commercial Smartphone-paired Breathalyzers-Set 1
Smartphone-paired mobile breathalyzer-Set 1: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
|
Commercial Smartphone-paired Breathalyzers-Set 2
Smartphone-paired mobile breathalyzer-Set 2: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breathalyzer Validation Study
Baseline characteristics by cohort
| Measure |
Commercial Smartphone-paired Breathalyzers-Set 1
n=10 Participants
Smartphone-paired mobile breathalyzer-Set 1: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
|
Commercial Smartphone-paired Breathalyzers-Set 2
n=10 Participants
Smartphone-paired mobile breathalyzer-Set 2: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
26.8 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI (mean ± SD)
|
24.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 4.3 • n=7 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 HoursPopulation: Group 1: Alcohoot, Evoc, BACtrack Mobile Pro, Intoxilyzer 240 (A). Group 2: BACtrack Vio, Drinkmate, Floome, Intoxilyzer 240 (B). Percent of Alcohol in Blood - grouped.
Difference in Breath Alcohol Concentration (BrAC) from police-grade (Intoxilyzer 240) and consumer smartphone-paired breath testing devices relative to Blood Alcohol Concentration (BAC) measured from blood draw after tertiary dose of alcohol.
Outcome measures
| Measure |
Alcohoot
n=10 Participants
Alcohoot branded smartphone-paired breathalyzer
|
BACtrack Mobile Pro
n=10 Participants
BACtrack Mobile Pro branded smartphone-paired breathalyzer
|
DRIVESAFE Evoc
n=10 Participants
DRIVESAFE Evoc branded smartphone-paired breathalyzer
|
Intoxilyzer 240 (A)
n=10 Participants
Intoxilyzer 240 police grade breathalyzer
|
BACtrack Vio
n=10 Participants
BACtrack Vio branded smartphone-paired breathalyzer
|
Drinkmate
n=10 Participants
Drinkmate branded smartphone-paired breathlyzer
|
Floome
n=10 Participants
Floome branded smartphone-paired breathalyzer
|
Intoxilyzer 240 (B)
n=10 Participants
Intoxilyzer 240 police grade breathalyzer
|
Percent of Alcohol in Blood
n=20 Participants
Percentage of Alcohol in Blood measured from blood draw
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Alcohol in Breath Variability
|
0.0912 percentage of alcohol
Standard Deviation 0.0164
|
0.0968 percentage of alcohol
Standard Deviation 0.0147
|
0.0694 percentage of alcohol
Standard Deviation 0.0074
|
0.0912 percentage of alcohol
Standard Deviation 0.0099
|
0.0746 percentage of alcohol
Standard Deviation 0.0312
|
0.0495 percentage of alcohol
Standard Deviation 0.0181
|
0.0770 percentage of alcohol
Standard Deviation 0.0194
|
0.0860 percentage of alcohol
Standard Deviation 0.0160
|
0.0996 percentage of alcohol
Standard Deviation 0.0165
|
SECONDARY outcome
Timeframe: 8 HoursMean difference in percent of blood in breath (BrAC) between the police-grade and personal, commercial breath testing devices
Outcome measures
| Measure |
Alcohoot
n=10 Participants
Alcohoot branded smartphone-paired breathalyzer
|
BACtrack Mobile Pro
n=10 Participants
BACtrack Mobile Pro branded smartphone-paired breathalyzer
|
DRIVESAFE Evoc
n=10 Participants
DRIVESAFE Evoc branded smartphone-paired breathalyzer
|
Intoxilyzer 240 (A)
n=10 Participants
Intoxilyzer 240 police grade breathalyzer
|
BACtrack Vio
n=10 Participants
BACtrack Vio branded smartphone-paired breathalyzer
|
Drinkmate
n=10 Participants
Drinkmate branded smartphone-paired breathlyzer
|
Floome
Floome branded smartphone-paired breathalyzer
|
Intoxilyzer 240 (B)
Intoxilyzer 240 police grade breathalyzer
|
Percent of Alcohol in Blood
Percentage of Alcohol in Blood measured from blood draw
|
|---|---|---|---|---|---|---|---|---|---|
|
Differences in Readings on Devices for Percentage of Alcohol in Breath
|
-0.000836 percentage of alcohol in breath
Interval -0.003066 to 0.001394
|
0.005853 percentage of alcohol in breath
Interval 0.003643 to 0.008064
|
-0.015698 percentage of alcohol in breath
Interval -0.017905 to -0.013491
|
-0.000405 percentage of alcohol in breath
Interval -0.00345 to 0.002639
|
-0.014616 percentage of alcohol in breath
Interval -0.017642 to -0.01159
|
-0.006004 percentage of alcohol in breath
Interval -0.009094 to -0.002915
|
—
|
—
|
—
|
Adverse Events
Commercial Smartphone-paired Breathalyzers-Set 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Commercial Smartphone-paired Breathalyzers-Set 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place