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Human Electrical-Impedance-Tomography Reconstruction Models

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Medical University of Vienna

Status and phase

Unknown
Phase 3

Conditions

Respiratory Monitoring

Treatments

Device: "electrical impedance tomography"

Study type

Interventional

Funder types

Other

Identifiers

NCT02773680
1917/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

160 participants in 1 patient group

Study cohort 1
Experimental group
Description:
"electrical impedance tomography"
Treatment:
Device: "electrical impedance tomography"

Trial contacts and locations

0

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Central trial contact

Stefan Boehme, MD

Data sourced from clinicaltrials.gov

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