A Multicenter Comparative Study of Saline Contrast Electrical Impedance Tomography Method Versus CTPA in the Diagnosis of Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- The ability of proportion of dead space ventilation to diagnose PE
研究概览
简要总结
The goal of this observational study is to compare the consistency of saline contrast Electrical Impedance Tomography(EIT) method and Computed Tomography Pulmonary Angiography (CTPA) in diagnosing acute pulmonary embolism. The main question it aims to answer is:
Can bedside saline contrast EIT method be used for the diagnosis of acute pulmonary embolism? The participants will undergo saline contrast EIT and CTPA examinations successively within 24 hours.
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
- •Patients with clinically suspected or confirmed acute pulmonary embolism (PE) presenting with acute respiratory failure;
- •Availability of CTPA results within 24 hours or scheduled to undergo CTPA within the next 24 hours;
- •Age >18 years; no gender restrictions;
- •Presence of central venous access (internal jugular or subclavian vein) or peripheral forearm venous access;
- •Willingness to participate with signed informed consent from either the patient or legal guardian.
排除标准
- •Pregnancy or lactation;
- •Relative contraindications to EIT examination (e.g., chest wall wounds at electrode belt placement site, presence of pacemakers);
- •Severe hypernatremia (serum sodium >155 mmol/L);
- •Inability to maintain expiratory breath-hold for ≥8 seconds;
- •BMI >50 or severe thoracic deformities;
- •Current extracorporeal membrane oxygenation (ECMO) therapy.
结局指标
主要结局
The ability of proportion of dead space ventilation to diagnose PE
时间窗: Within 24 hours before or after the CTPA examination
The participant undergoes a saline contrast EIT examination, after which the distribution of pulmonary ventilation and perfusion will be obtained, respectively. A V-Q map will be subsequently generated. Using offline EIT data analysis tool, the proportion of lung regions with ventilation but without perfusion is calculated, representing the proportion of dead space ventilation (expressed as a percentage). Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, Youden's index, accuracy, Kappa statistic, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) will be used to evaluate the ability of proportion of dead space ventilation to diagnose acute pulmonary embolism (PE).
次要结局
- The ability of proportion of V/Q matching to diagnose PE(Within 24 hours before or after the CTPA examination)
- The ability of proportion of shunt to diagnose PE(Within 24 hours before or after the CTPA examination)
- The ability of other indicators reflecting pulmonary ventilation and perfusion to diagnose PE(Within 24 hours before or after the CTPA examination)