Human Electrical-Impedance-Tomography Reconstruction Models

• ClinicalTrials.gov Identifier: NCT02773680
• Recruitment Status: Unknown
• First Posted: May 16, 2016
• Last Update Posted: May 16, 2016
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna

Tracking Information

• First Submitted Date: May 9, 2016
• First Posted Date: May 16, 2016
• Last Update Posted Date: May 16, 2016
• Study Start Date: May 2016
• Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2016)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 11, 2016)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Human Electrical-Impedance-Tomography Reconstruction Models
• Official Title: Assessment of CT-derived Thoracic Electrical-Impedance-Tomography Finite Element Models
• 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.

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Respiratory Monitoring

Intervention

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)

Study Arms

Experimental: Study cohort 1

"electrical impedance tomography"

Intervention: Device: "electrical impedance tomography"

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 11, 2016): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2017
• Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02773680
• Other Study ID Numbers: 1917/2015
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided

Investigators

• Principal Investigator: Stefan Boehme, MD; Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria

• PRS Account: Medical University of Vienna
• Verification Date: May 2016