Human Electrical-Impedance-Tomography Reconstruction Models

May 11, 2016 updated by: Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna

Assessment of CT-derived Thoracic Electrical-Impedance-Tomography Finite Element Models

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
approximately 1 year through study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
height
Time Frame: at the time-point of inclusion
at the time-point of inclusion
weight
Time Frame: at the time-point of inclusion
at the time-point of inclusion
gender
Time Frame: at the time-point of inclusion
at the time-point of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (ESTIMATE)

May 16, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1917/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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