Comparison of Computertomography Scan, Electrical Impedance Tomography, and Ultrasound of the Lung in Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorMedical University of Vienna
About this trial
The study focuses on regional lung examination, in particular on the differentiation between collapsed and hyperinflated lung areas. The purpose of the study is to elaborate common and discriminative elements between different lung imaging modalities in infants and to generate hypotheses for the bedside use of EIT and LUS in infants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients hospitalized at the Department of Pediatrics of the Medical University of Vienna who will get a CT scan of the thorax.
Patients aged up to 12 months
Disqualifiers
Unstable cardiovascular, respiratory and/or neurological conditions.
Sternotomy during the previous 15 days.
Thoracic skin lesions or wounds (including burns) on the thorax, where the EIT-electrode-belt would be placed.
Trial population
Infants receiving a CT scan of the thorax.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electrical impedance tomography and ultrasonography of the lung
Other interventionBoth EIT and LUS are non-invasive methods and do not pose any additional risk for the patient. The LuMon System with pediatric EIT belts (LuMon Belt, Sentec, Landquart, Switzerland) will be used. The belt will be placed on the thorax circumference of the infant and connected to the LuMonConnector (Sentec, Landquart, Switzerland). Small electrical currents (3 mA, 198 kHz) will be repetitively injected in rotation through adjacent electrode pairs, and voltage changes will be measured by all passive electrodes pairs (scan rate 48 Hz). Changes in lung electrical impedance will be continuously recorded for 5 minutes. EIT data will be analyzed off-line using Matlab (Mathworks, Natick, Massachusetts, USA). The regional tidal volume distribution, the homogeneity of tidal ventilation distribution, regional respiratory system compliance, and alveolar overdistension and collapse will be assessed. LUS will be performed by experienced users, with a 10 MHz linear transducer.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Comparison between CT and EIT
Estimate difference of lung cross-section between CT scan and EIT
Time frame
through study completion, an average of 1 year2
Comparison between CT and LUS
Comparison of diagnosis (presence of pathologic patterns including pneumothorax, emphysema, atelectasis, consolidation, ground glass opacity, bronchial wall thickening and/or dilatation) in CT and LUS
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Comparison between EIT and LUS
Comparison of dynamic parameters of dorsal and ventral regions
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov