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

November 18, 2024 updated by: Tobias Werther, Medical University of Vienna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants receiving a CT scan of the thorax.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between EIT and LUS
Time Frame: through study completion, an average of 1 year
Comparison of dynamic parameters of dorsal and ventral regions
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Tobias Werther, MD, PhD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 25, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1565/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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