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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic Accuracy of EIT-derived Dead Space Index (DI) for Pulmonary Embolism
Délai: 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.
|
Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic Accuracy of EIT-derived Matching Index (MI) for Pulmonary Embolism
Délai: 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 Matching Index (MI) measured by 3D-EIT for diagnosing pulmonary embolism, using CT pulmonary angiography (CTPA) as the reference standard.
|
Baseline (within 24 hours after CTPA for the PE cohort and at enrollment for the control cohort)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3D-EIT for PE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .