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NCT05546333 Clinical Trial

Comparing Electrical Impedance Tomography to Computed Tomographic Angiography

Pulmonary Embolism Clinical Trial

Official title:
Assessing the Effectiveness of Electrical Impedance Tomography Images to Detect Pulmonary Emboli Compared to Computed Tomographic Angiography

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05546333
Other study ID # 21-4600
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date June 1, 2025

Study information
Verified date May 2024
Source Colorado State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 63
Est. completion date June 1, 2025
Est. primary completion date May 23, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States UCHealth Medical Center of the Rockies Loveland Colorado

Sponsors (2)
Lead Sponsor Collaborator
Colorado State University UC Health Medical Center of the Rockies

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correspondence to CTA To assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli (PE). One year
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