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.
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.
Previous diagnosis of chronic pulmonary embolism or idiopathic pulmonary arterial hypertension.
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.
Other
Other
Pulsatile Electrical Impedance Tomography
Diagnostic testPulsatile 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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Beijing Tsinghua Chang Gung Hospital
Lead sponsor
Peking Union Medical College Hospital
Collaborator
Tsinghua University
Collaborator
First People's Hospital of Chenzhou
Collaborator
Loudi Central Hospital
Collaborator
