Effect of Breast Size on the Electrical Impedance Tomography Measurement

April 12, 2024 updated by: Czech Technical University in Prague

Effect of Women Breast Size on Lung Monitoring Using Electrical Impedance Tomography

Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The EIT measurement (PulmoVista 500, Dräger Medical, Germany) was performed in supine lying position. On every subject, an electrode belt of proper size based on the measured thorax circumference was placed. It was crucial to find a right position where it was possible to place the electrode belt over the breast tissue and then underneath the breast tissue, without changing the level and the position of the electrode belt on the thorax. Also, the position of the belt had to be between 4th and 6th intercostal space, as recommended by the manufacturer. The change of the position of the belt relative to the breast tissue was performed in a lying position by a slight pull of the buckled belt away from the subject´s body, so the subject could relocate the breast tissue over the belt using her own hands into the position as desired by the researcher.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Kladno, Czechia, 27201
        • Faculty of biomedical Engineering, Czech Technical University in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy female volunteers

Exclusion Criteria:

  • morbid obesity
  • standard exclusion criteria for electrical impedance tomography according to the manufacturer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy female volunteers
Data were obtained at two phases at supine horizontal position during spontaneous and forced breathing of the volunteers. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue.
Device: Electrical impedance tomography (EIT)
Non-invasive, radiation-free bedside lung monitoring using small alternating currents with no known side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional ventilation changes possibly caused by the breast tissue
Time Frame: 30 minutes
The dependence of the regional ventilation evaluated by EIT on the breast size on the regional ventilation was not confirmed.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female subjects enrollment in EIT studies and clinical applications
Time Frame: 30 minutes
Recommendation to include women in studies and clinical applications that use electrical impedance tomography for lung monitoring
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Investigators

  • Study Director: Karel Roubik, Prof. Ph.D., Faculty of biomedical Engineering, Czech Technical University in Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

May 31, 2014

Study Completion (Actual)

May 31, 2014

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JP/1/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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