ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000960550

Ethics application status

Approved

Date submitted

24/08/2015

Date registered

14/09/2015

Date last updated

22/08/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Negative sensitivity effects associated with the fingers and wrist on bioimpedance measurements in healthy participants.

Scientific title

Pilot study: In the general population does negative sensitivity have a detrimental effect, or not, on bioimpedance measurements of the fingers and wrist?

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

negative sensitivity in bioimpedance testing of the fingers and wrist.

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Bio impedance devices measure the opposition (impedance) of body tissues to a small applied alternating electrical current. Using a typical tetrapolar electrode arrangement, intended to reduce impedance contributions from the electrodes themselves, the current is delivered through one pair of surface electrodes and voltages measured across available voltage electrodes. Typically the voltage electrodes are placed several centimetres distant from the current electrodes. The two components of impedance, namely, resistance (opposition to the current passes through the tissue) and reactance (opposition due to capacitance of the membranes, tissue interfaces and non-ionic tissues) provide information about (1) the tissue fluid distribution and electrolyte composition and (2) cell membrane mass and status.

Bioimpedance testing applied involving six electrodes placed on hand with a voltage applied for 2 seconds which is not felt by the participant. 5 readings will be taken with ascending negative sensitivity applied to each bioimpedance measurement by switching the electrodes. One testing session of approximately 10 minutes with no further follow-up.

Intervention code [1]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Negative sensitivity effect size as assessed against finite element modelling.

Timepoint [1]

At each bioimpedance measurement taken during a single session.

Secondary outcome [1]

Impedance change related to finite element modelling.

Timepoint [1]

Following each measurement taken during a single session.

Eligibility

Key inclusion criteria

Healthy.

Minimum age

18 Years

Maximum age

25 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

For safety reasons those who have:
Implanted devices such as pacemakers
Pregnant women
Known medical conditions (heart disease)
Skin disease
Broken skin on hands,
Will be excluded

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Participant characteristics: about 10-15 males and 10-15 females of the ages of 18-25 years old. This is to ensure that a small but reliable sample size is obtained in participants of similar characteristics. Using other similar research done as a reference, this sample size should be enough to provide enough information to reach conclusive results.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2015

Actual

1/07/2016

Date of last participant enrolment

Anticipated

Actual

1/08/2016

Date of last data collection

Anticipated

Actual

1/08/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

University of Sydney

Address

NSW 2006

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Ti2 Medical Pty Ltd

Address [1]

11 Averill St,
Rhodes, NSW 2138

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney

Ethics committee address [1]

NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/07/2015

Ethics approval number [1]

2014/1005

Summary

Brief summary

Negative sensitivity is one of the most significant source of error in regards to the tetrapolar method used most commonly in bio-impedance (Grimnes & Martinsem 2006). The tetrapolar method consists of a pair of current carrying electrodes which sends tiny electrical current into a localised area. This current is then detected via another pair of electrodes, which help map out the resistance levels in the area. Numerous studies have been conducted making use of this method to help understand the underlying material composition of the area, without the need for time consuming imagery and surgeries (Oh & Sadleir 2005 and Moretti et al. 2011). Unfortunately a common error which occurs in this method, is the occurrence of negative sensitivity, which acts an opposing force and distorts measurements made with the tetrapolar method. In particular, impedance measurements made around the fingers and wrist area, which has the highest concentration of resistivity in the body (Foster & Lukaski 1996 and Gislason et al. 2010). Moreover, the use of FEM modelling and experimental data to help examine impedance readings have been well documented as a feasible method with good results for understanding the effects of errors in the execution of the tetrapolar method (Jafarppor et. al. 2011). While there are many causes where this error has affected measurements, there has yet to be any definitive research into negative sensitivity itself. Thus we hope to fill in the gaps left in the literature and conduct a pilot study into the origins and circumstances of negative sensitivity, rather than leaving it as an excuse for future error.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alistair McEwan

Address

The University of Sydney
NSW 2006

Country

Australia

Phone

+61293517256

Fax

alistair.mcewan@sydney.edu.au

Contact person for public queries

Name

Alistair McEwan

Address

The University of Sydney
NSW 2006

Country

Australia

Phone

+61293517256

Fax

alistair.mcewan@sydney.edu.au

Contact person for scientific queries

Name

Alistair McEwan

Address

The University of Sydney
NSW 2006

Country

Australia

Phone

+61293517256

Fax

alistair.mcewan@sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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