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临床试验/NCT02773680
NCT02773680Unknown3 期

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

Medical University of Vienna0 个研究点目标入组 160 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
3 期
入组人数
160
主要终点
Electrical Impedance Tomography Finite Element Model

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Electrical Impedance Tomography Finite Element Model

时间窗: 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

次要结局

  • weight(at the time-point of inclusion)
  • gender(at the time-point of inclusion)
  • height(at the time-point of inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ass.-Prof. Dr. Stefan Boehme

MD

Medical University of Vienna

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