Alcohol Detection Via Bioimpedance Mesurements

NCT01977157 | Completed

• 1 other identifier: 11-189
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Impedance cardiography; bioimpedance; spectroscopy; extracellular resistance; body composition; hemodynamics; alcohol

Outcome Measures

Primary Outcomes (1)

• Bioimpedance measurements

  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

Study Arms (1)

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

Interventions

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)

bioimpedance measurements while trinking alcohol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male subjects

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Study Officials

• Michael Czaplik, Dr. med.

  Department of Anaesthesiology ,Chair for Medical Information Technology Helmholtz Institute for Biomedical Engineering RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 6, 2013
• Study Start: July 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2013
• Last Updated: November 6, 2013

Record last verified: 2013-10

Locations

DE (1)