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NCT Number: NCT04989439

Comparison of Computertomography Scan, Electrical Impedance Tomography, and Ultrasound of the Lung in Infants

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.

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Electrical impedance tomography and ultrasonography of the lung

Other

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.

Primary outcomes

  1. Comparison between CT and EIT

    Time frame: through study completion, an average of 1 year

    Estimate difference of lung cross-section between CT scan and EIT

  2. Comparison between CT and LUS

    Time frame: through study completion, an average of 1 year

    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

Secondary outcomes

  1. Comparison between EIT and LUS

    Time frame: through study completion, an average of 1 year

    Comparison of dynamic parameters of dorsal and ventral regions

Study contacts

Contact information is provided by the study sponsor or research team.

Tobias Werther, MD, PhD

CONTACT

[email protected]

+4314040032320

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Comparison of Computertomography Scan, Electrical Impedance Tomography, and Ultrasound of the Lung in Infants - A Prospective Explorative Observational Study

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Aug 4, 2021
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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