3D-EIT for Diagnosis and Monitoring of Pulmonary Embolism

NCT07560293 | Not Yet Recruiting

• 1 other identifier: 3D-EIT for PE
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Embolism (Diagnosis); Venous Thromboembolism (VTE)

Keywords

Pulmonary Embolism; Electrical Impedance Tomography; Three-dimensional Imaging; Lung Perfusion; Ventilation-Perfusion Mismatch

Outcome Measures

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.

  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

  Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

Pulmonary Embolism; Disease; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04