3D-EIT for Diagnosis and Monitoring of Pulmonary Embolism
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Tsinghua Chang Gung Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Participants will be recruited from Beijing Tsinghua Changgung Hospital. The study population will include: (1) adult patients with a first episode of pulmonary embolism confirmed by CT pulmonary angiography, and (2) control participants without pulmonary embolism or deep vein thrombosis who are scheduled for saphenous vein radiofrequency ablation for varicose veins. Control participants will undergo screening to exclude venous thromboembolism before enrollment.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of EIT-derived Dead Space Index (DI) for Pulmonary Embolism
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of the Dead Space Index (DI) measured by 3D-EIT for diagnosing pulmonary embolism, using CT pulmonary angiography (CTPA) as the reference standard.
Time frame
Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)Secondary outcomes
1
Diagnostic Accuracy of EIT-derived Matching Index (MI) for Pulmonary Embolism
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of the Matching Index (MI) measured by 3D-EIT for diagnosing pulmonary embolism, using CT pulmonary angiography (CTPA) as the reference standard.
Time frame
Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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