Alcohol Detection Via Bioimpedance Mesurements

Completed

• Conditions: Healthy
• Interventions: Device: bioimpedance mesurements

• Registration Number: NCT01977157
• Lead Sponsor: RWTH Aachen University

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2012-10
• Status Verified: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-30
• Last Update Submitted: 2013-10-30
• Study First Posted: 2013-11-06
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bioimpedance measurements while trinking alcohol	bioimpedance mesurements	Bioimpedance spectroscopy (BIS) measurements on 12 healthy subjects were performed while they were drinking alkohol until reaching a BAC of 0.8 ‰.

Primary Outcome Measures

Name	Time	Method
Bioimpedance measurements	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).

Trial Locations

Locations (1)

Department of Anaesthesiology, University Hospital Aachen; 🇩🇪 Aachen, North Rhine-Westphalia, Germany