Effect of Breast Size on the Electrical Impedance Tomography Measurement

Not Applicable

Completed

• Conditions: Effect of Breast Tissue on EIT Lung Monitoring
• Interventions: Device: Electrical impedance tomography (EIT)

• Registration Number: NCT06369090
• Lead Sponsor: Czech Technical University in Prague

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.

Study Timeline

• Study Start: 2013-11-01
• Primary Completion: 2014-05-31
• Study Completion: 2014-05-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• healthy female volunteers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy female volunteers	Electrical impedance tomography (EIT)	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.

Primary Outcome Measures

Name	Time	Method
Regional ventilation changes possibly caused by the breast tissue	30 minutes	The dependence of the regional ventilation evaluated by EIT on the breast size on the regional ventilation was not confirmed.

Secondary Outcome Measures

Name	Time	Method
Female subjects enrollment in EIT studies and clinical applications	30 minutes	Recommendation to include women in studies and clinical applications that use electrical impedance tomography for lung monitoring

Trial Locations

Locations (1)

Faculty of Biomedical Engineering, Czech Technical University in Prague; 🇨🇿 Kladno, Czechia