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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic Accuracy of EIT-derived Dead Space Index (DI) for Pulmonary Embolism
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic Accuracy of EIT-derived Matching Index (MI) for Pulmonary Embolism
時間枠：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)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 3D-EIT for PE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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