3D-EIT for Diagnosis and Monitoring of Pulmonary Embolism (TIDE-PE)
Prospective Validation of Three-Dimensional Electrical Impedance Tomography for the Diagnosis, Risk Stratification, and Longitudinal Monitoring of Pulmonary Embolism
Descripción general del estudio
Estado
Descripción detallada
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.
Statistical analyses will include estimation of reference ranges in the control cohort, receiver operating characteristic (ROC) analysis for diagnostic performance, correlation analyses between EIT and CTPA-derived parameters, and longitudinal analyses of repeated EIT measurements in the PE cohort.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic Accuracy of EIT-derived Dead Space Index (DI) for Pulmonary Embolism
Periodo de tiempo: Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)
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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.
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Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic Accuracy of EIT-derived Matching Index (MI) for Pulmonary Embolism
Periodo de tiempo: Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)
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Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of the Matching Index (MI) measured by 3D-EIT for diagnosing pulmonary embolism, using CT pulmonary angiography (CTPA) as the reference standard.
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Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 3D-EIT for PE
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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