Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?

• Sponsor: St. Luke's Hospital and Health Network, Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02580318
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 13.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Concentration Values; Alcohol Intoxication	Device: breathalyzer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: all study participants subjects consumed alcohol to a BrAC of 0.1 and then performed the following manipulations while using the breathalyzer: poor effort, hyperventilation (immediate), hyperventilation (after 5 minutes), hyperventilation (after 10 minutes), drinking water (immediate), drinking water (after 5 minutes)	Device: breathalyzer

Outcome Measures

Primary Outcome Measures

1. Percent Alcohol Concentration Measured by Breathalyzer [20 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's Hospital	Bethlehem	Pennsylvania	United States	18015

Sponsors and Collaborators

• St. Luke's Hospital and Health Network, Pennsylvania

Investigators

• Principal Investigator: Holly Stankewicz, D.O., St. Luke's University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Holly Stankewicz, D.O., Attending physician and faculty emergency medicine resiency, St. Luke's Hospital and Health Network, Pennsylvania
• ClinicalTrials.gov Identifier: NCT02580318
• Other Study ID Numbers: SLHN 2015-28
• First Posted: Oct 20, 2015
• Last Update Posted: Sep 15, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Alcoholic Intoxication

Study Results

Participant Flow

Pre-assignment Detail	54 participants.

Arm/Group Title	All Study Participants
Arm/Group Description	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)
Period Title: Overall Study
STARTED	54
Poor Effort	53
Hyperventilation (Immediate)	54
Hyperventilation (5 Minutes)	54
Hyperventilation (10 Minutes)	54
Drinking Water (Immediate)	51
Drinking Water (5 Minutes)	54
COMPLETED	54
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	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 Participants	54
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	54 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	22 40.7%
Male	32 59.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	54 100%

Outcome Measures

1. Primary Outcome

Title	Percent Alcohol Concentration Measured by Breathalyzer
Time Frame	20 minutes

Outcome Measure Data

Analysis Population Description

number of participants that completed breath alcohol content are reported.

Arm/Group Title	All Study Participants
Arm/Group Description	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)
Measure Participants	54
poor effort	0.099 (.010)
hyperventilation (immediate)	0.086 (0.011)
hyperventilation (5 minutes)	0.099 (0.009)
hyperventilation (10minutes)	0.099 (0.011)
drinking water(immediate)	0.084 (0.011)
drinking water (5 minutes)	0.096 (0.013)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments	this p value is calculated for poor effort
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (poor effort)
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments	p value calculated for hyperventilation (immediate)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (hyperventilation - immediate)
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments	p value calculated for hyperventilation (after 5 minutes)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after hyperventilation)
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments	p value calculated for hyperventilation (after 10 minutes)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (10 minutes after hyperventilation)
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments	p value calculated for drinking water (immediate)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (immediately after drinking water)
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments	p value calculated for drinking water (5 minutes)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after drinking water)
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	12 hours
Arm/Group Title	All Study Participants
Arm/Group Description	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)
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	4/54 (7.4%)
Gastrointestinal disorders
vomiting	2/54 (3.7%)
Nervous system disorders
vertigo	2/54 (3.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.