Pulmonary EmbolismNCT05546333
Comparing Electrical Impedance Tomography to Computed Tomographic Angiography
An observational study of Pulmonary Embolism, run by Colorado State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Electrical impedance tomography
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 9 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR) for a suspected pulmonary embolism
Who may be able to join
- 18 years of age or older
- Undergoing a CTA of the chest at MCR
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCHealth Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
Official title: 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Electrical impedance tomography
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyDevice
Also called EIT
Non-invasive measure of electrical impedance in the body, with data collected on electrodes on the surface of the body
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correspondence to CTA
To assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli (PE).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 May 2023
- Primary completion23 May 2024
- Study completion9 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- UC Health Medical Center of the Rockies
- Responsible party
- Sponsor
- Investigators
- Jennifer L Mueller, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546333
- Sponsor's protocol ID
- 21-4600
- Status last verified
- Jun 2025
- First submitted
- 15 Sep 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Electrical Impedance Tomography Images to Detect Pulmonary Emboli Compared to Computed Tomographic Angiography
- ClinicalTrials.gov ID
- NCT05546333
- Acronym / sponsor ID
- 21-4600
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- UC Health Medical Center of the Rockies
- Study start
- 1 May 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 9 Jun 2026 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving CTA | – | Device: Electrical impedance tomographyPatients who will receive a CTA due to clinical need will be imaged with electrical impedance tomography in addition to the CTA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR) for a suspected pulmonary embolism
Key inclusion criteria (2 listed)
- 18 years of age or older
- Undergoing a CTA of the chest at MCR
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomographyAlso: EITNon-invasive measure of electrical impedance in the body, with data collected on electrodes on the surface of the body | Device | Patients receiving CTA |
Primary outcome
Correspondence to CTA
Time frame: One year
To assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli (PE).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Mueller, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correspondence to CTA (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.