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Clinical Trials in China / NCT07724197
Recruiting Observational

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

NCT07724197 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tsinghua Chang Gung Hospital
Phase
Observational
Started
2026-01-02
Last updated
2026-08-04

Condition(s) studied

Pulmonary Embolism Acute

Investigational drug(s) / intervention(s)

Pulsatile Electrical Impedance Tomography

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism — At baseline or index EIT assessment
    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.

Trial sites (4)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality Not Yet Recruiting
Chenzhou First People's Hospital Chenzhou Hunan Recruiting
Loudi Central Hospital Loudi Hunan Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07724197 on ClinicalTrials.gov ↗ ← All trials in China