Effect of Breast Tissue on EIT Lung MonitoringNCT06369090
Effect of Breast Size on the Electrical Impedance Tomography Measurement
A study testing Electrical impedance tomography (EIT) in people with Effect of Breast Tissue on EIT Lung Monitoring, run by Czech Technical University in Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Breast Tissue on EIT Lung Monitoring
- What is being tested?
- Electrical impedance tomography (EIT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2013to 31 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy female volunteers
Who cannot join
- morbid obesity
- standard exclusion criteria for electrical impedance tomography according to the manufacturer
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of Biomedical Engineering, Czech Technical University in Prague
Kladno, 27201
About this study
Official title: 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.
Read the 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.
- Being tested
- Electrical impedance tomography (EIT)
- Keywords
- Breast tissue, Electrical impedance tomography, Regional ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomography (EIT)Device
Non-invasive, radiation-free bedside lung monitoring using small alternating currents with no known side effects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electrical impedance tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
Female subjects enrollment in EIT studies and clinical applications
Recommendation to include women in studies and clinical applications that use electrical impedance tomography for lung monitoring
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Nov 2013
- Primary completion31 May 2014
- Study completion31 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Breast Tissue on EIT Lung MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, Prof. Ph.D., Study director, Faculty of Biomedical Engineering, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369090
- Sponsor's protocol ID
- JP/1/2013
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Women Breast Size on Lung Monitoring Using Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT06369090
- Acronym / sponsor ID
- JP/1/2013
- Keywords
- Breast tissue, Electrical impedance tomography, Regional ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 31 May 2014 (actual)
- Study completion
- 31 May 2014 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions.
| Arm | Type | Receives |
|---|---|---|
| Healthy female volunteers | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy female volunteers
Key exclusion criteria (2 listed)
- morbid obesity
- standard exclusion criteria for electrical impedance tomography according to the manufacturer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomography (EIT)Non-invasive, radiation-free bedside lung monitoring using small alternating currents with no known side effects. | Device | Healthy female volunteers |
Primary outcome
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.
1 secondary outcome
Female subjects enrollment in EIT studies and clinical applications
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Roubik, Prof. Ph.D. study director
Faculty of Biomedical Engineering, Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical impedance tomography (EIT) in people with Effect of Breast Tissue on EIT Lung Monitoring, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional ventilation changes possibly caused by the breast tissue (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.