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.
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
275
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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChenzhou First People's Hospital
Chenzhou, Hunan, China
RECRUITINGLoudi Central Hospital
Loudi, Hunan, China
NOT_YET_RECRUITINGDiagnostic 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.
Time frame: At baseline or index EIT assessment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge
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