Human Electrical-Impedance-Tomography Reconstruction Models

Respiratory Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02773680
• Other study ID #: 1917/2015
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 9, 2016
• Last updated: May 11, 2016
• Start date: May 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2016
• Source: Medical University of Vienna
• Contact: Stefan Boehme, MD
• Phone: +43 40400 41020
• Email: stefan.boehme[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical Impedance Tomography Finite Element Model	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	No
Secondary	height		at the time-point of inclusion	No
Secondary	weight		at the time-point of inclusion	No
Secondary	gender		at the time-point of inclusion	No