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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT04989439
Collaborator
(none)
10
1
36.4
0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Electrical impedance tomography and ultrasonography of the lung

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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Computertomography Scan, Electrical Impedance Tomography, and Ultrasound of the Lung in Infants - A Prospective Explorative Observational Study
Actual Study Start Date :
Jul 19, 2021
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Comparison between CT and EIT [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 [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 Outcome Measures

  1. Comparison between EIT and LUS [through study completion, an average of 1 year]

    Comparison of dynamic parameters of dorsal and ventral regions

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tobias Werther, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04989439
Other Study ID Numbers:
  • 1565/2021
First Posted:
Aug 4, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tobias Werther, Principal Investigator, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022