HealthyAlkBISNCT01977157
Alcohol Detection Via Bioimpedance Mesurements
An observational study of Healthy, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- bioimpedance mesurements
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male subjects
Who may be able to join
- Healthy male subjects
- able to give informed consent
- Inconspicuous laboratory and drug screening
Who cannot join
- electrophobica
- alcoholphobica, -allergy
- metallic ans / or electric implants
- underage persons
- interactively medication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- bioimpedance mesurements
- Keywords
- Impedance cardiography, bioimpedance, spectroscopy, extracellular resistance, body composition, hemodynamics, alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioimpedance mesurementsDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 ‰. Receives: Device: bioimpedance mesurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Czaplik, Dr. med., Principal investigator, Department of Anaesthesiology ,Chair for Medical Information Technology Helmholtz Institute for Biomedical Engineering RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977157
- Sponsor's protocol ID
- 11-189
- Acronym
- AlkBIS
- Status last verified
- Oct 2013
- First submitted
- 24 Oct 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Detection Via Bioimpedance Mesurements
- ClinicalTrials.gov ID
- NCT01977157
- Acronym / sponsor ID
- AlkBIS / 11-189
- Conditions
- Healthy
- Keywords
- Impedance cardiography, bioimpedance, spectroscopy, extracellular resistance, body composition, hemodynamics, alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bioimpedance measurements while trinking alcohol | – | Device: bioimpedance mesurementsBioimpedance spectroscopy (BIS) measurements on 12 healthy subjects were performed while they were drinking alkohol until reaching a BAC of 0.8 ‰. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male subjects
Key inclusion criteria (3 listed)
- Healthy male subjects
- able to give informed consent
- Inconspicuous laboratory and drug screening
Key exclusion criteria (5 listed)
- electrophobica
- alcoholphobica, -allergy
- metallic ans / or electric implants
- underage persons
- interactively medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioimpedance mesurementsBioimpedance 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) | Device | bioimpedance measurements while trinking alcohol |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Czaplik, Dr. med. principal investigator
Department of Anaesthesiology ,Chair for Medical Information Technology Helmholtz Institute for Biomedical Engineering RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioimpedance measurements (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.