A Multicenter Retrospective and Prospective Diagnostic Observational Study of Pulsatile Electrical Impedance Tomography for Diagnosis, Risk Stratification, and Dynamic Monitoring of Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 7
- 主要终点
- Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Pulsatile Electrical Impedance Tomography (Diagnostic Test)
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.
干预措施: Pulsatile Electrical Impedance Tomography (Diagnostic Test)
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.
干预措施: Pulsatile Electrical Impedance Tomography (Diagnostic Test)
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.
干预措施: Pulsatile Electrical Impedance Tomography (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism
时间窗: 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.
次要结局
- 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)
研究者
Weiwei Wu
Vice President and Chair, Department of Vascular Surgery; Professor and Chief Physician
Beijing Tsinghua Chang Gung Hospital