3D-EIT for Diagnosis and Monitoring of Pulmonary Embolism (NCT07560293) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
3D-EIT for Diagnosis and Monitoring of Pulmonary Embolism
115 participantsStarted 2026-05-01
Plain-language summary
This prospective observational study aims to validate three-dimensional electrical impedance tomography (3D-EIT) as a non-invasive bedside tool for the diagnosis and longitudinal monitoring of pulmonary embolism (PE). The study will include a PE cohort and a control cohort without PE or venous thromboembolism (VTE). Using algorithms that separate ventilation and perfusion signals, 3D-EIT-derived indices, including the Matching Index (MI), Dead Space Index (DI), and Shunt Index (SI), will be quantified. The diagnostic performance of MI and DI will be evaluated against computed tomography pulmonary angiography (CTPA), and their associations with PE severity, risk stratification, and treatment response will be explored. This study is expected to support the clinical translation of 3D-EIT as a radiation-free bedside functional imaging tool for PE management.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years or older
* Body mass index (BMI) less than 50 kg/m²
* Able to provide written informed consent
* first episode of pulmonary embolism confirmed by CT pulmonary angiography (CTPA), with or without CT venography (CTV)
Exclusion Criteria:
* Previous diagnosis of pulmonary embolism
* Pregnancy
* Thoracic deformity or chest wall abnormality preventing proper placement of the EIT electrode belt
* Contraindications to EIT use, including implantable cardioverter-defibrillator, pacemaker, implanted pumps, or chest wounds limiting electrode placement
* Concurrent participation in another interventional clinical study Hemodynamic instability requiring emergency intervention that precludes completion of the EIT examination (PE cohort only)
* Any other condition judged by the investigator to make the participant unsuitable for study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Accuracy of EIT-derived Dead Space Index (DI) for Pulmonary Embolism
Timeframe: Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)