NCT05546333

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
May 2023Jun 2026

First Submitted

Initial submission to the registry

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2026

Expected
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

September 15, 2022

Last Update Submit

June 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correspondence to CTA

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

    One year

Study Arms (1)

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

Interventions

Non-invasive measure of electrical impedance in the body, with data collected on electrodes on the surface of the body

Also known as: EIT
Patients receiving CTA

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR) for a suspected pulmonary embolism

You may qualify if:

  • years of age or older
  • Undergoing a CTA of the chest at MCR

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCHealth Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Jennifer L Mueller, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 19, 2022

Study Start

May 1, 2023

Primary Completion

May 23, 2024

Study Completion (Estimated)

June 9, 2026

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations