- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02580318
Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?
September 11, 2017 updated by: Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18015
- St. Luke's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Alcohol Concentration Measured by Breathalyzer
Time Frame: 20 minutes
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Holly Stankewicz, D.O., St. Luke's University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 10, 2015
First Submitted That Met QC Criteria
October 16, 2015
First Posted (Estimate)
October 20, 2015
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 11, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLHN 2015-28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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