Clinical trial NCT02773680: Human Electrical-Impedance-Tomography Reconstruction Models
Official title: Assessment of CT-derived Thoracic Electrical-Impedance-Tomography Finite Element Models
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Respiratory Monitoring
Keywords: respiration
monitoring, physiologic
diagnostic techniques, respiratory system
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Electrical Impedance Tomography Finite Element Model
timeFrame: approximately 1 year through study completion
Secondary outcomes:
measure: height
timeFrame: at the time-point of inclusion
measure: weight
timeFrame: at the time-point of inclusion
measure: gender
timeFrame: at the time-point of inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Anesthesia, Intensive Care Medicine and Pain Management, Medical University of Vienna, Austria
name: Stefan Boehme, MD
role: PRINCIPAL_INVESTIGATOR
References: