Effect of Breast Size on the Electrical Impedance Tomography Measurement

NCT ID: NCT06369090

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-01
• Study Completion Date: 2014-05-31

Brief Summary

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.

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.

Conditions

Effect of Breast Tissue on EIT Lung Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Electrical impedance tomography (EIT)

Intervention Type: DEVICE

Non-invasive, radiation-free bedside lung monitoring using small alternating currents with no known side effects.

Interventions

Electrical impedance tomography (EIT)

Non-invasive, radiation-free bedside lung monitoring using small alternating currents with no known side effects.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• healthy female volunteers

Exclusion Criteria

• morbid obesity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Czech Technical University in Prague

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karel Roubik, Prof. Ph.D.

Role: STUDY_DIRECTOR

Faculty of Biomedical Engineering, Czech Technical University in Prague

Locations

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, , Czechia

Countries

Czechia

Other Identifiers

JP/1/2013

Identifier Type: -

Identifier Source: org_study_id