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Comparing Electrical Impedance Tomography to Computed Tomographic Angiography

Sponsor
Colorado State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05546333
Collaborator
Medical Center of the Rockies (Other)
63
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The study aim is to determine whether electrical impedance tomography (EIT) is equivalent in the detection of pulmomary emboli compared to Computed Tomographic Angiography (CTA). EIT is a non-invasive, non-ionizing functional imaging technique that can be performed at bedside. Electrical impedance tomography data will be collected on individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR). The primary outcome measure is to assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli. The study will include up to 63 participants. EIT data will be collected for up to 20 minutes during tidal breathing and for approximately five to ten seconds during breath-holding.

Condition or Disease Intervention/Treatment Phase
  • Device: Electrical impedance tomography

Study Design

Study Type:
Observational
Anticipated Enrollment :
63 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing the Effectiveness of Electrical Impedance Tomography Images to Detect Pulmonary Emboli Compared to Computed Tomographic Angiography
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients receiving CTA

Patients who will receive a CTA due to clinical need will be imaged with electrical impedance tomography in addition to the CTA.

Device: Electrical impedance tomography
Non-invasive measure of electrical impedance in the body, with data collected on electrodes on the surface of the body
Other Names:
  • EIT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correspondence to CTA [One year]

      To assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli (PE).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 18 years of age or older

    • Undergoing a CTA of the chest at MCR

    Exclusion Criteria:

    • Under 18 years of age

    • Body mass index (BMI) > 30

    • Individuals with known thoracic metal implants or devices, such as pacemakers (internal and external), staples, or spinal and rib hardware

    • Individuals deemed by the research team as too unstable to safely apply the EIT belt, such as hemodynamic or respiratory instability (e.g., intubated patients), and individuals with unstable spinal injuries

    • Open wounds at the site of electrode belt application

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Colorado State University
    • Medical Center of the Rockies

    Investigators

    • Principal Investigator: Jennifer L Mueller, PhD, Colorado State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Colorado State University
    ClinicalTrials.gov Identifier:
    NCT05546333
    Other Study ID Numbers:
    • 21-4600
    First Posted:
    Sep 19, 2022
    Last Update Posted:
    Sep 19, 2022
    Last Verified:
    Sep 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
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Sep 19, 2022