Pulsatile Electrical Impedance Tomography for Diagnosis and Monitoring of Acute Pulmonary Embolism

NCT07724197 | Not Yet Recruiting

• 3 other identifiers: 2D-EIT-PE-2026L24602126890-0-01
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pulmonary Embolism Acute

Keywords

Acute Pulmonary Embolism; Pulsatile Electrical Impedance Tomography; Ventilation-Perfusion; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between EIT-derived parameters and CTPA embolic burden

  At baseline or index assessment

• Differences in EIT-derived parameters across thrombus locations and clinical risk strata

  At baseline or index assessment

• Correlation between EIT-derived parameters and clinical indicators

  At baseline or index assessment

• Dynamic changes in EIT-derived parameters during treatment and follow-up

  Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge

Study Arms (4)

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

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

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

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

Interventions

Pulsatile Electrical Impedance Tomography DIAGNOSTIC_TEST

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.

Also known as: Pulsatile EIT, Electrical Impedance Tomography, EIT

Prospective Non-PE Controls; Prospective PE Patients; Retrospective Healthy Controls; Retrospective PE Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Peking Union Medical College Hospital: collaborator
• Tsinghua University: collaborator
• First People's Hospital of Chenzhou: collaborator
• Loudi Central Hospital: collaborator

Study Sites (4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Chenzhou First People's Hospital

Chenzhou, Hunan, 423000, China

Location

Loudi Central Hospital

Loudi, Hunan, 417000, China

Location

Study Officials

• weiwei Wu, MD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jiazheng Li, MD

CONTACT

+86-18810886832; ljzs00357@btch.edu.cn

weiwei wu, MD

CONTACT

+86-13426397036; weiwei.wu@btch.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President and Chair, Department of Vascular Surgery; Professor and Chief Physician

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 24, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)