Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Electrical-Impedance-Tomography Reconstruction Models

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773680
Recruitment Status : Unknown
Verified May 2016 by Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE May 9, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • height [ Time Frame: at the time-point of inclusion ]
  • weight [ Time Frame: at the time-point of inclusion ]
  • gender [ Time Frame: at the time-point of inclusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Electrical-Impedance-Tomography Reconstruction Models
Official Title  ICMJE Assessment of CT-derived Thoracic Electrical-Impedance-Tomography Finite Element Models
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Respiratory Monitoring
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Study cohort 1
"electrical impedance tomography"
Intervention: Device: "electrical impedance tomography"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773680
Other Study ID Numbers  ICMJE 1917/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ass.-Prof. Dr. Stefan Boehme, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Boehme, MD Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria
PRS Account Medical University of Vienna
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP