Prospective Validation of Three-Dimensional Electrical Impedance Tomography for the Diagnosis, Risk Stratification, and Longitudinal Monitoring of Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 主要终点
- Diagnostic Accuracy of EIT-derived Dead Space Index (DI) for Pulmonary Embolism
研究概览
简要总结
This prospective observational study aims to validate three-dimensional electrical impedance tomography (3D-EIT) as a non-invasive bedside tool for the diagnosis and longitudinal monitoring of pulmonary embolism (PE). The study will include a PE cohort and a control cohort without PE or venous thromboembolism (VTE). Using algorithms that separate ventilation and perfusion signals, 3D-EIT-derived indices, including the Matching Index (MI), Dead Space Index (DI), and Shunt Index (SI), will be quantified. The diagnostic performance of MI and DI will be evaluated against computed tomography pulmonary angiography (CTPA), and their associations with PE severity, risk stratification, and treatment response will be explored. This study is expected to support the clinical translation of 3D-EIT as a radiation-free bedside functional imaging tool for PE management.
详细描述
Pulmonary embolism (PE) is a major cause of morbidity and mortality. Computed tomography pulmonary angiography (CTPA) is the current reference standard for PE diagnosis, but it is limited by radiation exposure, contrast administration, and poor suitability for bedside or repeated dynamic assessment. Three-dimensional electrical impedance tomography (3D-EIT) is a non-invasive, radiation-free imaging technique that enables bedside evaluation of regional lung ventilation and perfusion.
The objective of this study is to validate the clinical utility of 3D-EIT for the diagnosis, risk stratification, and longitudinal monitoring of PE. The study will focus on EIT-derived ventilation-perfusion parameters, including the Matching Index (MI), Dead Space Index (DI), and Shunt Index (SI).
This is a prospective, single-center, observational case-control study conducted at Beijing Tsinghua Changgung Hospital. Two cohorts will be enrolled:
- A control cohort without PE or VTE, recruited from patients scheduled for saphenous vein radiofrequency ablation for varicose veins who meet predefined screening criteria.
- A PE cohort including patients with a first episode of PE confirmed by CTPA. Participants in the control cohort will undergo one 3D-EIT examination to establish reference ranges for MI, DI, and SI. Participants in the PE cohort will undergo 3D-EIT within 24 hours after diagnostic CTPA. Repeated EIT examinations will be performed after thrombolytic therapy when applicable, at hospital discharge, and at 1-month follow-up to evaluate dynamic changes over time.
The primary objective is to assess the diagnostic performance of MI and DI for identifying PE using CTPA as the reference standard. Secondary objectives include evaluating the association of EIT-derived indices with PE severity, CTPA-based obstruction burden, risk stratification category, and temporal changes following treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Body mass index (BMI) less than 50 kg/m²
- •Able to provide written informed consent
- •first episode of pulmonary embolism confirmed by CT pulmonary angiography (CTPA), with or without CT venography (CTV)
排除标准
- •Previous diagnosis of pulmonary embolism
- •Pregnancy
- •Thoracic deformity or chest wall abnormality preventing proper placement of the EIT electrode belt
- •Contraindications to EIT use, including implantable cardioverter-defibrillator, pacemaker, implanted pumps, or chest wounds limiting electrode placement
- •Concurrent participation in another interventional clinical study Hemodynamic instability requiring emergency intervention that precludes completion of the EIT examination (PE cohort only)
- •Any other condition judged by the investigator to make the participant unsuitable for study participation
结局指标
主要结局
Diagnostic Accuracy of EIT-derived Dead Space Index (DI) for Pulmonary Embolism
时间窗: Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of the Dead Space Index (DI) measured by 3D-EIT for diagnosing pulmonary embolism, using CT pulmonary angiography (CTPA) as the reference standard.
次要结局
- Diagnostic Accuracy of EIT-derived Matching Index (MI) for Pulmonary Embolism(Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort))
研究者
Weiwei Wu
Chief Physician
Beijing Tsinghua Chang Gung Hospital