Pulsatile Electrical Impedance Tomography for Diagnosis and Monitoring of Acute Pulmonary Embolism (EIT-PE)
A Multicenter Retrospective and Prospective Diagnostic Observational Study of Pulsatile Electrical Impedance Tomography for Diagnosis, Risk Stratification, and Dynamic Monitoring of Acute Pulmonary Embolism
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: jiazheng LI, MD
- Telefonnummer: +86-18810886832
- E-Mail: ljzs00357@btch.edu.cn
Studieren Sie die Kontaktsicherung
- Name: weiwei wu, MD
- Telefonnummer: +86-13426397036
- E-Mail: weiwei.wu@btch.edu.cn
Studienorte
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 102218
- Noch keine Rekrutierung
- Beijing Tsinghua Changgung Hospital
-
Kontakt:
- jiazheng LI, MD
- Telefonnummer: +86-18810886832
- E-Mail: ljzs00357@btch.edu.cn
-
Kontakt:
- weiwei wu, MD
- Telefonnummer: +86-13426397036
- E-Mail: weiwei.wu@btch.edu.cn
-
Hauptermittler:
- weiwei wu, MD
-
Beijing, Beijing Municipality, China, 100730
- Noch keine Rekrutierung
- Peking Union Medical College Hospital
-
Kontakt:
- YUN LONG, MD
- Telefonnummer: +86-10-69155707
- E-Mail: 2801634102@qq.com
-
Unterermittler:
- yun long, MD
-
-
Hunan
-
Chenzhou, Hunan, China, 423000
- Rekrutierung
- Chenzhou First People's Hospital
-
Kontakt:
- shaofei xu, MD
- Telefonnummer: +86-13617356697
- E-Mail: 742025632@qq.com
-
Kontakt:
- E-Mail: 742025632@qq.com
-
Unterermittler:
- shaofei xu, MD
-
Loudi, Hunan, China, 417000
- Noch keine Rekrutierung
- Loudi Central Hospital
-
Kontakt:
- junbiao huang, MD
- Telefonnummer: +8618873820320
- E-Mail: 695997696@qq.com
-
Unterermittler:
- junbiao huang, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index.
These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism.
This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.
Andere Namen:
|
|
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.
|
Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index.
These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism.
This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.
Andere Namen:
|
|
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.
|
Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index.
These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism.
This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.
Andere Namen:
|
|
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.
|
Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index.
These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism.
This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism
Zeitfenster: 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.
|
At baseline or index EIT assessment
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Correlation between EIT-derived parameters and CTPA embolic burden
Zeitfenster: At baseline or index assessment
|
The correlation between MI, DI, SI and the embolic burden assessed by CT pulmonary angiography will be analyzed.
|
At baseline or index assessment
|
|
Differences in EIT-derived parameters across thrombus locations and clinical risk strata
Zeitfenster: At baseline or index assessment
|
MI, DI, and SI will be compared among patients with different thrombus locations and different clinical risk strata.
|
At baseline or index assessment
|
|
Correlation between EIT-derived parameters and clinical indicators
Zeitfenster: At baseline or index assessment
|
The correlation between MI, DI, SI and clinical indicators, including D-dimer levels and echocardiographic indicators of right heart function, will be analyzed.
|
At baseline or index assessment
|
|
Dynamic changes in EIT-derived parameters during treatment and follow-up
Zeitfenster: Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge
|
Changes and percentage changes in MI, DI, and SI will be assessed at baseline, during treatment when applicable, before discharge, and at 1 month after discharge.
|
Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: weiwei Wu, MD, Beijing Tsinghua Changgeng Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2D-EIT-PE-2026
- L246021 (Andere Zuschuss-/Finanzierungsnummer: Beijing Natural Science Foundation-Daxing Innovation Joint Fund)
- 26890-0-01 (Andere Kennung: Institutional Review Board of Beijing Tsinghua Changgung Hospital)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .