Faculty of Biomedical Engineering, Czech Technical University in Prague
Kladno, 27201, Czechia
Completed
NCT Number: NCT06369090
Effect of Breast Size on the Electrical Impedance Tomography Measurement
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.
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Notify MeKey information
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- healthy female volunteers
Exclusion criteria
- morbid obesity
- standard exclusion criteria for electrical impedance tomography according to the manufacturer
Treatment and study plan
Electrical impedance tomography (EIT)
DeviceNon-invasive, radiation-free bedside lung monitoring using small alternating currents with no known side effects.
Primary outcomes
-
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.
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Czech Technical University in Prague
Other
Registry information
Official study title
Effect of Women Breast Size on Lung Monitoring Using Electrical Impedance Tomography
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Apr 16, 2024
- Registry last updated
- Apr 16, 2024
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.