Human Electrical-Impedance-Tomography Reconstruction Models

NCT02773680 | Unknown Phase 3

• 1 other identifier: 1917/2015
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Monitoring

Keywords

respiration; monitoring, physiologic; diagnostic techniques, respiratory system

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• height

  at the time-point of inclusion

• weight

  at the time-point of inclusion

• gender

  at the time-point of inclusion

Study Arms (1)

Study cohort 1

EXPERIMENTAL

"electrical impedance tomography"

Device: "electrical impedance tomography"

Interventions

"electrical impedance tomography" DEVICE

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 cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Boehme, MD

  Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Boehme, MD

CONTACT

+43 40400 41020; stefan.boehme@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 16, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 16, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share