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

Primary Purpose

Alcohol Concentration Values, Alcohol Intoxication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
breathalyzer
Sponsored by
St. Luke's Hospital and Health Network, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Concentration Values

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Luke's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all study participants

Arm Description

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)

Outcomes

Primary Outcome Measures

Percent Alcohol Concentration Measured by Breathalyzer

Secondary Outcome Measures

Full Information

First Posted
September 10, 2015
Last Updated
September 11, 2017
Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02580318
Brief Title
Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
Official Title
Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital and Health Network, Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Concentration Values, Alcohol Intoxication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all study participants
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
breathalyzer
Primary Outcome Measure Information:
Title
Percent Alcohol Concentration Measured by Breathalyzer
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Stankewicz, D.O.
Organizational Affiliation
St. Luke's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7136772
Citation
Jones AW. Quantitative measurements of the alcohol concentration and the temperature of breath during a prolonged exhalation. Acta Physiol Scand. 1982 Mar;114(3):407-12. doi: 10.1111/j.1748-1716.1982.tb07002.x.
Results Reference
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Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?

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