Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.
4 de mayo de 2026 actualizado por: University of Sao Paulo General Hospital
Chronic thromboembolic pulmonary hypertension (CTEPH) is a condition in which old blood clots block the blood vessels in the lungs, making it harder for the heart to pump blood through the lungs. Surgery called pulmonary thromboendarterectomy can remove these clots and improve blood flow, but doctors need reliable ways to evaluate lung blood flow before and after surgery.
This study will evaluate a bedside imaging method called electrical impedance tomography (EIT), which can measure how blood flows through different regions of the lungs without radiation or invasive procedures. Patients undergoing surgery for CTEPH will be monitored with EIT before and after surgery, and the results will be compared with standard lung perfusion imaging.
The goal of this study is to determine whether EIT can provide useful information about lung blood flow and changes after surgery, and whether it could serve as a complementary bedside tool to help monitor patients with CTEPH.
Descripción general del estudio
Estado
Reclutamiento
Descripción detallada
Chronic thromboembolic pulmonary hypertension (CTEPH) results from persistent obstruction of the pulmonary arteries by organized thromboembolic material and is a potentially curable cause of pulmonary hypertension. Pulmonary thromboendarterectomy is the treatment of choice for eligible patients and leads to significant improvement in pulmonary perfusion and hemodynamics.
Assessment of regional pulmonary perfusion is essential in the management of CTEPH. While perfusion SPECT/CT is commonly used for this purpose, it cannot be performed at the bedside and involves exposure to ionizing radiation. Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique that allows bedside assessment of lung ventilation and pulmonary perfusion through analysis of pulsatility-related impedance changes.
In this prospective diagnostic study, pulmonary perfusion assessed by EIT will be evaluated in patients undergoing pulmonary thromboendarterectomy and compared with perfusion SPECT/CT. EIT measurements will be obtained in the perioperative period, and perfusion changes will be analyzed using quantitative indices derived from impedance signals. The study focuses on the feasibility and performance of EIT as a bedside method for assessing pulmonary perfusion changes associated with surgical treatment of CTEPH.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
36
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marcelo BP Amato, MD PhD
- Número de teléfono: +55113061-7361
- Correo electrónico: marcelo.amato@hc.fm.usp.br
Copia de seguridad de contactos de estudio
- Nombre: Jaomar JC Salazar, MD
- Número de teléfono: +5511966477244
- Correo electrónico: jaomar@usp.br
Ubicaciones de estudio
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São Paulo
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São Paulo, São Paulo, Brasil, 05403-900
- Reclutamiento
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
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Contacto:
- Marcelo BP Amato, MD PhD
- Número de teléfono: +55113061-7361
- Correo electrónico: marcelo.amato@hc.fm.usp.br
-
Contacto:
- Jaomar JC Salazar, MD
- Número de teléfono: +5511966477244
- Correo electrónico: jaomar@usp.br
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) followed at the Pulmonology Service of InCor-HCFMUSP and scheduled for pulmonary thromboendarterectomy at InCor-FMUSP.
Exclusion Criteria:
- Age under 18 years
- Pregnancy
- Structural heart disease (atrial septal defect, ventricular septal defect, or valvular heart disease)
- Cardiac arrhythmias
- Use of a cardiac pacemaker or other implantable electronic device
- Skin lesions on the thoracic region at the site of EIT electrode belt placement
- Absence of central venous access on the day of the preoperative protocol evaluation
- Difficulty understanding the procedures to be performed
- Refusal to participate in the study (non-signing of the Informed Consent Form)
- Refusal by the attending medical team
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Diagnostic Imaging Ar.
Patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary thromboendarterectomy will be evaluated using electrical impedance tomography (EIT) for assessment of regional pulmonary perfusion in the preoperative and postoperative periods.
EIT-derived perfusion indices will be analyzed and compared with imaging-based thrombus burden and pulmonary perfusion assessed by SPECT-CT.
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Non-invasive, radiation-free bedside assessment of pulmonary perfusion using Electrical Impedance Tomography (EIT).
EIT will be performed using the Enlight 2100 system (Timpel Medical®, Brazil) in the preoperative and postoperative periods of pulmonary thromboendarterectomy.
Pulmonary perfusion will be assessed through analysis of pulsatility signals and first-pass kinetics following hypertonic saline bolus injection, generating regional perfusion maps and quantitative indices, including the wasted ventilatory index.
Data will be analyzed offline.
Pulmonary perfusion assessment performed using single-photon emission computed tomography (SPECT) with technetium-99m-labeled macroaggregated albumin, fused with non-contrast chest computed tomography (CT) acquired during both inspiratory and expiratory phases.
The fusion of functional perfusion images from SPECT with anatomical images from CT allows regional assessment of pulmonary perfusion and thromboembolic burden.
This examination will be performed in the preoperative period and during postoperative follow-up and will serve as a reference imaging modality for comparison with Electrical Impedance Tomography-derived perfusion measures.
Pulmonary thromboendarterectomy performed according to standard institutional clinical practice for the treatment of chronic thromboembolic pulmonary hypertension.
This surgical procedure is conducted solely for clinical indication and is not investigational.
Imaging and monitoring assessments included in this study do not alter the surgical technique or perioperative clinical management.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation of perfusion maps obtained by Electrical Impedance Tomography (EIT) in the pre- and postoperative period using the wasted ventilation index..
Periodo de tiempo: From the preoperative period to the immediate postoperative period during intensive care unit stay (on the day of surgery).
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Change in pulmonary perfusion assessed by Electrical Impedance Tomography (EIT) using the Enlight 2100 system (Timpel Medical®, Brazil), quantified by the wasted ventilatory index derived from regional perfusion maps, comparing preoperative and postoperative measurements in patients undergoing pulmonary thromboendarterectomy.
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From the preoperative period to the immediate postoperative period during intensive care unit stay (on the day of surgery).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of pulmonary perfusion assessed by Electrical Impedance Tomography and SPECT-CT.
Periodo de tiempo: From the preoperative period to the postoperative follow-up (up to 6 months after surgery).
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Comparison of changes in regional pulmonary perfusion assessed by Electrical Impedance Tomography (EIT) and by SPECT-CT imaging, expressed as percentage variation between preoperative and postoperative evaluations in patients undergoing pulmonary thromboendarterectomy.
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From the preoperative period to the postoperative follow-up (up to 6 months after surgery).
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Incidence of adverse events related to Electrical Impedance Tomography perfusion assessment.
Periodo de tiempo: From the preoperative period to hospital discharge, up to approximately 30 days
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Incidence and type of adverse events related to pulmonary perfusion assessment using Electrical Impedance Tomography, including events associated with the use of hypertonic saline injection.
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From the preoperative period to hospital discharge, up to approximately 30 days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of life assessed by SF-36 questionnaire after pulmonary thromboendarterectomy.
Periodo de tiempo: Up to 6 months after surgery.
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Quality of life assessed using the Short Form-36 (SF-36) questionnaire during outpatient follow-up after pulmonary thromboendarterectomy.
Scores range from 0 to 100, where higher scores indicate better quality of life.
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Up to 6 months after surgery.
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Correlation between EIT-derived pulsatility and hemodynamic parameter.
Periodo de tiempo: From the preoperative period to the immediate postoperative period (during intensive care unit stay).
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Correlation between changes in pulsatility (ΔZsys) assessed by Electrical Impedance Tomography and hemodynamic parameters, including stroke volume, cardiac output, and mean pulmonary artery pressure, measured using thermodilution via pulmonary artery catheter.
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From the preoperative period to the immediate postoperative period (during intensive care unit stay).
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Change in plasma sodium concentration after hypertonic saline injection
Periodo de tiempo: From baseline (before saline injection) to up to 2 hours after injection during hospitalization.
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Change in plasma sodium concentration measured before and after hypertonic saline injection used for Electrical Impedance Tomography perfusion assessment, expressed in mEq/L.
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From baseline (before saline injection) to up to 2 hours after injection during hospitalization.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.
- Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
- Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
- Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
- Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.
- Borges JB, Suarez-Sipmann F, Bohm SH, Tusman G, Melo A, Maripuu E, Sandstrom M, Park M, Costa EL, Hedenstierna G, Amato M. Regional lung perfusion estimated by electrical impedance tomography in a piglet model of lung collapse. J Appl Physiol (1985). 2012 Jan;112(1):225-36. doi: 10.1152/japplphysiol.01090.2010. Epub 2011 Sep 29.
- Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.
- Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.
- Jenkins DP, Madani M, Mayer E, Kerr K, Kim N, Klepetko W, Morsolini M, Dartevelle P. Surgical treatment of chronic thromboembolic pulmonary hypertension. Eur Respir J. 2013 Mar;41(3):735-42. doi: 10.1183/09031936.00058112. Epub 2012 Nov 8.
- Vonk-Noordegraaf A 2nd, Janse A, Marcus JT, Bronzwaer JG, Postmust PE, Faes TJ, De Vries PM. Determination of stroke volume by means of electrical impedance tomography. Physiol Meas. 2000 May;21(2):285-93. doi: 10.1088/0967-3334/21/2/308.
- Zadehkoochak M, Blott BH, Hames TK, George RF. Pulmonary perfusion and ventricular ejection imaging by frequency domain filtering of EIT (electrical impedance tomography) images. Clin Phys Physiol Meas. 1992;13 Suppl A:191-6. doi: 10.1088/0143-0815/13/a/037.
- Barber DC. Quantification in impedance imaging. Clin Phys Physiol Meas. 1990;11 Suppl A:45-56. doi: 10.1088/0143-0815/11/4a/306.
- Eyuboglu BM, Brown BH. Methods of cardiac gating applied potential tomography. Clin Phys Physiol Meas. 1988;9 Suppl A:43-8. doi: 10.1088/0143-0815/9/4a/008.
- Brown BH. Electrical impedance tomography (EIT): a review. J Med Eng Technol. 2003 May-Jun;27(3):97-108. doi: 10.1080/0309190021000059687.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de febrero de 2025
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
10 de febrero de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2026
Publicado por primera vez (Actual)
11 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 78916224.4.0000.0068
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .