Effect of Breast Size on the Electrical Impedance Tomography Measurement

NCT06369090 | Completed

• 1 other identifier: JP/1/2013
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Breast Tissue on EIT Lung Monitoring

Keywords

Breast tissue; Electrical impedance tomography; Regional ventilation

Outcome Measures

Primary Outcomes (1)

• Regional ventilation changes possibly caused by the breast tissue

  The dependence of the regional ventilation evaluated by EIT on the breast size on the regional ventilation was not confirmed.

  30 minutes

Secondary Outcomes (1)

• Female subjects enrollment in EIT studies and clinical applications

  30 minutes

Study Arms (1)

Healthy female volunteers

EXPERIMENTAL

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)

Interventions

Electrical impedance tomography (EIT) DEVICE

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

Healthy female volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The eligibility is based on natural physical differences of the female anatomy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy female volunteers

You may not qualify if:

• morbid obesity

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Study Officials

• Karel Roubik, Prof. Ph.D.

  Faculty of Biomedical Engineering, Czech Technical University in Prague

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions.

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: November 1, 2013
• Primary Completion: May 31, 2014
• Study Completion: May 31, 2014
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)