Human Electrical-Impedance-Tomography Reconstruction Models
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ClinicalTrials.gov Identifier: NCT02773680 |
Recruitment Status : Unknown
Verified May 2016 by Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna.
Recruitment status was: Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
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Condition or disease | Intervention/treatment | Phase |
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Respiratory Monitoring | Device: "electrical impedance tomography" | Phase 3 |
A major drawback of EIT is its relatively poor spatial resolution and its limitation in measuring changes in bioimpedance as compared to a reference state (and not absolute quantities). Therefore, the technique cannot differentiate between extrapulmonary structures (muscles, thorax, heart, large vessels, spine, etc.) and non-aerated lung tissues - which is a major limitation for the clinical use of information derived from EIT-imaging. Moreover, current EIT-reconstruction algorithms are based on the consideration of a complete circular thoracic shape and do not take into account the body contours and lung borders.
The investigators are convinced that EIT-derived dynamic bedside lung imaging can be advanced by morphing computed tomography (CT) scans of the respective thoracic levels with concomitant EIT images - thus enhancing EIT-image information with CT-data. Integrating the anatomy of thoracic shape and lung borders provided by high-spatial resolution multi detector CT-scans (MDCT) with high-temporal resolution EIT has the potential to improve image quality considerably. This data can be used to compute mean EIT-reconstruction models that further offer the possibility to develop novel and clinically meaningful EIT parameters.
Therefore, the investigators hypothesize that by integration of CT-scan information of body and lung contours (and by computing different EIT reconstruction models) the current methodological limitations of EIT technology can be overcome.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Assessment of CT-derived Thoracic Electrical-Impedance-Tomography Finite Element Models |
Study Start Date : | May 2016 |
Estimated Primary Completion Date : | November 2016 |
Estimated Study Completion Date : | June 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Study cohort 1
"electrical impedance tomography"
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Device: "electrical impedance tomography"
One continous electrical impedance tomography (EIT) measurement per subject of approximately 5 minutes duration (2 min prior to MDCT scanning, during end-inspiratory MDCT acquisition and 2 min after MDCT scanning) |
- Electrical Impedance Tomography Finite Element Model [ Time Frame: approximately 1 year through study completion ]Based on CT-derived thorax, lung and heart contours we propose to calculate human finite element models (FEM) for EIT analysis
- height [ Time Frame: at the time-point of inclusion ]
- weight [ Time Frame: at the time-point of inclusion ]
- gender [ Time Frame: at the time-point of inclusion ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- spontaneous breathing male subjects
- age > 18,
- clinical indication for thoracic CT scanning,
- matching of weight and height to the predefined model-thresholds
Exclusion Criteria:
- pre-existing chronic pulmonary disease
- skin lesions / wounds in the thoracic plane where the EIT SensorBelt will be attached
- known allergy against any ingredient of the used ContactAgent
- abnormalities in thoracic shape as defined by the radiologist in charge (e.g. extreme kyphosis, funnel chest, pigeon breast, multiple rip fractures)
- pneumothorax
- pace maker (external and internal)
- other implanted electrical devices
- other methods measuring bioimpedance

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773680
Contact: Stefan Boehme, MD | +43 40400 41020 | stefan.boehme@meduniwien.ac.at |
Principal Investigator: | Stefan Boehme, MD | Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria |
Responsible Party: | Ass.-Prof. Dr. Stefan Boehme, MD, Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT02773680 |
Other Study ID Numbers: |
1917/2015 |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | May 16, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
respiration monitoring, physiologic diagnostic techniques, respiratory system |