Alcohol Detection Via Bioimpedance Mesurements (AlkBIS)

October 30, 2013 updated by: RWTH Aachen University

Examination if the bioimpendanz measurement can be used for the determination of the alcohol content in human blood.

Furthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer and one blood test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this clinical trail it will be analyzed, if it is possible to assess the blood alcohol content (BAC) with the bioimpedance devices (SFB7, ImpediMed; Nicomo).

This technology is non-invasive an can be measured by using conductive electrodes, capacitive electrodes or inductive measurement systems.

The BIS-values will be compared with an official breathanalyzer (Alcotest 7110 Evidential MK III, Dräger, Lübeck, Germany).

Furthermore one blood sample will be taken and analyzed with the ADH method as the current gold standard at the end of the trail.

Study Type

Observational

Enrollment (Actual)

12

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

  • Germany
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Department of Anaesthesiology, University Hospital Aachen

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy male subjects

Description

Inclusion Criteria:

  • Healthy male subjects
  • able to give informed consent
  • Inconspicuous laboratory and drug screening

Exclusion Criteria:

  • electrophobica
  • alcoholphobica, -allergy
  • metallic ans / or electric implants
  • underage persons
  • interactively medication

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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bioimpedance measurements while trinking alcohol
Bioimpedance spectroscopy (BIS) measurements on 12 healthy subjects were performed while they were drinking alkohol until reaching a BAC of 0.8 ‰.
Device: bioimpedance mesurements
Bioimpedance measurements were conducted with a BIS device (SFB7, ImpediMed, Pinkeba, Australia) covering a frequency range between 5 kHz and 1 MHz and an ICG device (Niccomo, medis, Ilmenau, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioimpedance measurements
Time Frame: 4 hours
Evaluation if the bioimpedance measurements can be used to verify and quantify the alcohol content in human blood. Bioimpedance measurements will be conducted with the BIS device (SFB7, ImpediMed) covering a frequency range between 5 kHz and 1 MHz and an ICG device (Niccomo,medis) operating at. The whole-body and hand-to-hand bioimpedance will be analyzed. Extracellular resistance (Re), intracellular resistance (Ri) and capacitive effects (Cm) are calculated by using the Cole model Grimnes (2000).
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Czaplik, Dr. med., Department of Anaesthesiology ,Chair for Medical Information Technology Helmholtz Institute for Biomedical Engineering RWTH Aachen University

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

July 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-189

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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