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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
Sponsor:
Information provided by (Responsible Party):
Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna

Study Description
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Brief Summary:
Current EIT analyses are based on the assumption of a circular thorax-shape and do not provide any information on lung borders. The aim is to obtain the body and lung border contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds of anthropometric data (gender = male; height; weight) for calibration of more realistic EIT reconstruction models.

Condition or disease Intervention/treatment Phase
Respiratory Monitoring Device: "electrical impedance tomography" Phase 3

Detailed Description:

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 Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Study cohort 1
"electrical impedance tomography"
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. height [ Time Frame: at the time-point of inclusion ]
  2. weight [ Time Frame: at the time-point of inclusion ]
  3. gender [ Time Frame: at the time-point of inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Stefan Boehme, MD +43 40400 41020 stefan.boehme@meduniwien.ac.at

Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Stefan Boehme, MD Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria
More Information
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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
Keywords provided by Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna:
respiration
monitoring, physiologic
diagnostic techniques, respiratory system