- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05546333
Comparing Electrical Impedance Tomography to Computed Tomographic Angiography
June 9, 2025 updated by: Colorado State University
Assessing the Effectiveness of Electrical Impedance Tomography Images to Detect Pulmonary Emboli Compared to Computed Tomographic Angiography
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
63
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Loveland, Colorado, United States, 80538
- UCHealth Medical Center of the Rockies
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR) for a suspected pulmonary embolism
Description
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
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
Cohorts and Interventions
Group / Cohort |
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.
|
Non-invasive measure of electrical impedance in the body, with data collected on electrodes on the surface of the body
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correspondence to CTA
Time Frame: One year
|
To assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli (PE).
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer L Mueller, PhD, Colorado State University
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)
May 1, 2023
Primary Completion (Actual)
May 23, 2024
Study Completion (Estimated)
June 9, 2026
Study Registration Dates
First Submitted
September 15, 2022
First Submitted That Met QC Criteria
September 15, 2022
First Posted (Actual)
September 19, 2022
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 9, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-4600
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
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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