An observational study in Infant ALL, Computed Tomography and Electric Impedance, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Medical University of Vienna · Observational
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.
Lung imaging has become increasingly important across medical specialties for diagnostic, monitoring, and investigative purposes in acute respiratory distress syndrome (ARDS). Lung computer tomography (CT) is the gold standard chest imaging technique to evaluate lung morphology and to perform a quantitative analysis of lung tissue aeration and recruitment. In the last decades, electrical impedance tomography (EIT) has gained a lot of attention in monitoring functional lung parameters. EIT is a non-invasive, bedside radiation-free functional imaging modality for continuous monitoring of lung ventilation and perfusion. Functional chest examinations with EIT are considered clinically relevant, especially for monitoring regional lung ventilation in patients with respiratory support, but also to assess aeration in preterm and term infants. In comparison with dynamic CT, EIT proved to be useful in bedside adjustments of mechanical ventilation with immediate feedback in adult patients. EIT lacks the spatial resolution of other imaging modalities but it is compact in size, uses no ionizing radiation, and gives functional images with high temporal resolution. As CT scans expose patients to ionizing radiation, there are no investigative studies comparing EIT with CT scans in newborns and infants. This would be useful, particularly, for correlating the reference impedance image with a CT scan to correctly calibrate anatomical structures and to differentiate between dependent and non-dependent lung areas. Likewise, lung ultrasound (LUS) has been increasingly used for the diagnosis of different lung conditions. Some validation studies compared LUS with CT scans and classified LUS to be a valid tool to assess regional and global lung aeration also in newborns. To our knowledge, there are no comparative studies between EIT and LUS in newborns and infants.
The main objective is to compare different lung imaging modalities in infants with and without lung disease using the CT scan as reference method. The study focuses on regional lung examination. 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 this group of patients.
The CT scan is part of the routine care of the participants. No additional CT examinations will be performed for this study. LUS and EIT will be performed immediately before or after the planned CT scan. Both LUS and EIT measurements will be performed with mobile devices and will take approximately 20 minutes.
114 studies on the registry are indexed under Lung Injury; 33 are open to participants now.
This study's planned enrollment of 10 is below the median of 100 across 35 observational studies indexed under Lung Injury.
Browse Lung Injury studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Infants receiving a CT scan of the thorax.
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Exclusion Criteria:
Both 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.
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 year
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 year
Comparison between EIT and LUS
Comparison of dynamic parameters of dorsal and ventral regions
Time frame: through study completion, an average of 1 year
Plan to share: No
Started Jul 2021 (actual). Primary completion is estimated for Jul 2028, 84 months after the start.
Of 24 observational studies under Lung Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 101. This study's planned 84 months is above that.
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