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OpenTrials
Completed

NCT Number: NCT01977157

Alcohol Detection Via Bioimpedance Mesurements

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Anaesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bioimpedance mesurements

Device

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)

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: AlkBIS

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 6, 2013
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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