Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.

NCT07577700 | Recruiting

• 1 other identifier: 78916224.4.0000.0068
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Thromboendarterectomy; Pulmonary Embolism and Thrombosis

Keywords

Pulmonary Perfusion; Electrical Impedance Tomography (EIT); Cardiac Output; Resistência Vascular Pulmonar

Outcome Measures

Primary Outcomes (1)

• Evaluation of perfusion maps obtained by Electrical Impedance Tomography (EIT) in the pre- and postoperative period using the wasted ventilation index..

  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.

  From the preoperative period to the immediate postoperative period during intensive care unit stay (on the day of surgery).

Secondary Outcomes (2)

• Comparison of pulmonary perfusion assessed by Electrical Impedance Tomography and SPECT-CT.

  From the preoperative period to the postoperative follow-up (up to 6 months after surgery).

• Incidence of adverse events related to Electrical Impedance Tomography perfusion assessment.

  From the preoperative period to hospital discharge, up to approximately 30 days

Other Outcomes (3)

• Quality of life assessed by SF-36 questionnaire after pulmonary thromboendarterectomy.

  Up to 6 months after surgery.

• Correlation between EIT-derived pulsatility and hemodynamic parameter.

  From the preoperative period to the immediate postoperative period (during intensive care unit stay).

• Change in plasma sodium concentration after hypertonic saline injection

  From baseline (before saline injection) to up to 2 hours after injection during hospitalization.

Study Arms (1)

Diagnostic Imaging Ar.

EXPERIMENTAL

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.

Diagnostic Test: Electrical Impedance Tomography (EIT).; Diagnostic Test: Pulmonary Perfusion SPECT-CT.; Procedure: Pulmonary Thromboendarterectomy.

Interventions

Electrical Impedance Tomography (EIT). DIAGNOSTIC_TEST

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.

Diagnostic Imaging Ar.

Pulmonary Perfusion SPECT-CT. DIAGNOSTIC_TEST

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.

Diagnostic Imaging Ar.

Pulmonary Thromboendarterectomy. PROCEDURE

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.

Diagnostic Imaging Ar.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) followed at the Pulmonology Service of InCor-HCFMUSP and scheduled for pulmonary thromboendarterectomy at InCor-FMUSP.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (14)

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  PMID: 1587100 BACKGROUND

• 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.

  PMID: 10847195 BACKGROUND

• 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.

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• 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.

  PMID: 21969018 BACKGROUND

• 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.

  PMID: 22700839 BACKGROUND

• 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.

  PMID: 25173341 BACKGROUND

• 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.

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• 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.

  PMID: 24898545 BACKGROUND

• 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.

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• Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

  PMID: 19186406 BACKGROUND

• Brown BH. Electrical impedance tomography (EIT): a review. J Med Eng Technol. 2003 May-Jun;27(3):97-108. doi: 10.1080/0309190021000059687.

  PMID: 12775455 BACKGROUND

• 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.

  PMID: 21960654 BACKGROUND

• 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.

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  PMID: 2286047 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Marcelo BP Amato, MD PhD

CONTACT

+55113061-7361; marcelo.amato@hc.fm.usp.br

Jaomar JC Salazar, MD

CONTACT

+5511966477244; jaomar@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients undergoing pulmonary thromboendarterectomy will be evaluated for pulmonary perfusion before and after surgery, as well as for hemodynamic measurements using electrical impedance tomography.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: May 11, 2026
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)