Pulsatile Electrical Impedance Tomography for Diagnosis and Monitoring of Acute Pulmonary Embolism (EIT-PE)

A Multicenter Retrospective and Prospective Diagnostic Observational Study of Pulsatile Electrical Impedance Tomography for Diagnosis, Risk Stratification, and Dynamic Monitoring of Acute Pulmonary Embolism

This multicenter observational diagnostic study aims to evaluate pulsatile electrical impedance tomography (EIT) for the diagnosis and monitoring of acute pulmonary embolism. The study includes a retrospective phase and a prospective phase. EIT-derived ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index will be compared with CT pulmonary angiography and relevant clinical indicators. The study is designed to assess whether EIT can provide a noninvasive, bedside, radiation-free method for pulmonary embolism diagnosis, risk stratification, and dynamic treatment monitoring.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Embolism Acute
• Intervention / Treatment: Diagnostic test: Pulsatile Electrical Impedance Tomography

Detailed Description

Pulmonary embolism is an important type of venous thromboembolism and may be associated with substantial morbidity and mortality. CT pulmonary angiography is commonly used as the reference standard for diagnosis, but it has limitations, including radiation exposure, use of iodinated contrast agents, and limited feasibility for continuous bedside monitoring in some critically ill patients.

Electrical impedance tomography is a noninvasive functional imaging technique that can be performed at the bedside and does not involve radiation. This study will evaluate a pulsatile EIT-based approach for assessing pulmonary ventilation and perfusion. The main EIT-derived parameters include the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index.

The retrospective phase will collect existing clinical and EIT data from patients with CTPA-confirmed acute pulmonary embolism and healthy controls. These data will be used to compare EIT parameters between groups, evaluate diagnostic performance, and explore optimal cutoff values.

The prospective phase will enroll patients newly diagnosed with acute pulmonary embolism and healthy volunteers. EIT examinations will be performed during routine clinical evaluation and follow-up. EIT parameters will be compared with CTPA findings, clinical risk stratification, D-dimer levels, echocardiographic indicators, and clinical outcomes. For patients with pulmonary embolism, serial EIT measurements may be used to evaluate dynamic changes during treatment and follow-up.

This is an observational study. Participants will not be assigned to any treatment by the study protocol, and clinical management will be determined by the treating physicians according to routine clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 275

Contacts and Locations

• Study Contact: Name: jiazheng LI, MD; Phone Number: +86-18810886832; Email: ljzs00357@btch.edu.cn
• Study Contact Backup: Name: weiwei wu, MD; Phone Number: +86-13426397036; Email: weiwei.wu@btch.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102218
      • Beijing Tsinghua Changgung Hospital
      • Contact: jiazheng LI, MD; Phone Number: +86-18810886832; Email: ljzs00357@btch.edu.cn
      • Contact: weiwei wu, MD; Phone Number: +86-13426397036; Email: weiwei.wu@btch.edu.cn
      • Principal Investigator: weiwei wu, MD
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
      • Contact: YUN LONG, MD; Phone Number: +86-10-69155707; Email: 2801634102@qq.com
      • Sub-Investigator: yun long, MD
  • Hunan
    • Chenzhou, Hunan, China, 423000
      • Chenzhou First People's Hospital
      • Contact: shaofei xu, MD; Phone Number: +86-13617356697; Email: 742025632@qq.com
      • Contact: Email: 742025632@qq.com
      • Sub-Investigator: shaofei xu, MD
    • Loudi, Hunan, China, 417000
      • Loudi Central Hospital
      • Contact: junbiao huang, MD; Phone Number: +8618873820320; Email: 695997696@qq.com
      • Sub-Investigator: junbiao huang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults with acute pulmonary embolism and control participants from the retrospective and prospective phases. Retrospective participants include patients with CTPA-confirmed acute pulmonary embolism and healthy controls with available EIT and clinical data. Prospective participants include patients newly diagnosed with acute pulmonary embolism and patients with suspected acute pulmonary embolism in whom pulmonary embolism is not confirmed by CTPA or CTPA plus CTV. All prospective participants will provide written informed consent.

Description

Inclusion Criteria:

• Adults aged 18 years or older. For retrospective PE cases: patients with acute pulmonary embolism confirmed by CT pulmonary angiography, with completed pulsatile electrical impedance tomography examination, adequate image data, and available clinical information.

For retrospective healthy controls: adults without evidence of lower-extremity venous thrombosis, with normal D-dimer levels, simplified Wells score ≤1, and no pulmonary embolism-related symptoms or history.

For prospective PE patients: patients newly diagnosed with pulmonary embolism by CT pulmonary angiography or CT pulmonary angiography plus CT venography, with body mass index less than 50 kg/m², who voluntarily participate and provide written informed consent.

For prospective non-PE controls: patients with suspected acute pulmonary embolism who undergo CT pulmonary angiography or CT pulmonary angiography plus CT venography, but in whom pulmonary embolism is not confirmed, who voluntarily participate and provide written informed consent.

Exclusion Criteria:

• Previous diagnosis of chronic pulmonary embolism or idiopathic pulmonary arterial hypertension.

Acute exacerbation of chronic obstructive pulmonary disease, acute heart failure, acute myocardial infarction, or other severe cardiopulmonary diseases that may interfere with study assessment.

Pregnancy or lactation. Thoracic deformity. Contraindications to EIT examination, including automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implanted pumps, or other conditions unsuitable for EIT electrode belt placement.

Participation in another clinical trial during the same period, for prospective participants.

Unstable vital signs requiring emergency rescue, leaving no time to complete EIT examination, for prospective participants.

Any other condition considered unsuitable for participation by the investigators.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective PE Cases; Patients aged 18 years or older with acute pulmonary embolism confirmed by CT pulmonary angiography, with completed pulsatile electrical impedance tomography examination and available clinical data in the retrospective phase.	Diagnostic test: Pulsatile Electrical Impedance Tomography; Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index. These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism. This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.; Other Names: EIT; Pulsatile EIT; Electrical Impedance Tomography
Retrospective Healthy Controls; Adults in the retrospective phase without evidence of lower-extremity venous thrombosis, with normal D-dimer levels, simplified Wells score ≤1, and no pulmonary embolism-related symptoms or history.	Diagnostic test: Pulsatile Electrical Impedance Tomography; Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index. These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism. This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.; Other Names: EIT; Pulsatile EIT; Electrical Impedance Tomography
Prospective PE Patients; Patients aged 18 years or older newly diagnosed with pulmonary embolism by CT pulmonary angiography or CT pulmonary angiography plus CT venography, who voluntarily participate and provide written informed consent.	Diagnostic test: Pulsatile Electrical Impedance Tomography; Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index. These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism. This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.; Other Names: EIT; Pulsatile EIT; Electrical Impedance Tomography
Prospective Non-PE Controls; Patients aged 18 years or older with suspected acute pulmonary embolism who undergo CT pulmonary angiography or CT pulmonary angiography plus CT venography, but in whom pulmonary embolism is not confirmed. These participants voluntarily participate and provide written informed consent in the prospective phase.	Diagnostic test: Pulsatile Electrical Impedance Tomography; Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index. These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism. This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.; Other Names: EIT; Pulsatile EIT; Electrical Impedance Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism	The diagnostic performance of EIT-derived ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index for distinguishing acute pulmonary embolism from non-PE controls will be evaluated using the area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, negative predictive value, and optimal cutoff values, with CT pulmonary angiography as the reference standard.	At baseline or index EIT assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between EIT-derived parameters and CTPA embolic burden	The correlation between MI, DI, SI and the embolic burden assessed by CT pulmonary angiography will be analyzed.	At baseline or index assessment
Differences in EIT-derived parameters across thrombus locations and clinical risk strata	MI, DI, and SI will be compared among patients with different thrombus locations and different clinical risk strata.	At baseline or index assessment
Correlation between EIT-derived parameters and clinical indicators	The correlation between MI, DI, SI and clinical indicators, including D-dimer levels and echocardiographic indicators of right heart function, will be analyzed.	At baseline or index assessment
Dynamic changes in EIT-derived parameters during treatment and follow-up	Changes and percentage changes in MI, DI, and SI will be assessed at baseline, during treatment when applicable, before discharge, and at 1 month after discharge.	Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Collaborators: Peking Union Medical College Hospital; First People's Hospital of Chenzhou; Tsinghua University; Loudi Central Hospital
• Investigators: Principal Investigator: weiwei Wu, MD, Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 16, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Risk Stratification; Acute Pulmonary Embolism; Pulsatile Electrical Impedance Tomography; Ventilation-Perfusion
• Other Study ID Numbers: 2D-EIT-PE-2026; L246021 (Other Grant/Funding Number: Beijing Natural Science Foundation-Daxing Innovation Joint Fund); 26890-0-01 (Other Identifier: Institutional Review Board of Beijing Tsinghua Changgung Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No