Human Electrical-Impedance-Tomography Reconstruction Models

Phase 3

• Conditions: Respiratory Monitoring
• Interventions: Device: "electrical impedance tomography"

• Registration Number: NCT02773680
• Lead Sponsor: Medical University of Vienna

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 Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-16
• Last Update Posted: 2016-05-16
• Primary Completion: 2016-11
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

• spontaneous breathing male subjects
• age > 18,
• clinical indication for thoracic CT scanning,
• matching of weight and height to the predefined model-thresholds

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study cohort 1	"electrical impedance tomography"	"electrical impedance tomography"

Primary Outcome Measures

Name	Time	Method
Electrical Impedance Tomography Finite Element Model	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

Name	Time	Method
weight	at the time-point of inclusion
gender	at the time-point of inclusion
height	at the time-point of inclusion