Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.
2026年5月4日 更新者：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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Marcelo BP Amato, MD PhD
- 电话号码：+55113061-7361
- 邮箱：marcelo.amato@hc.fm.usp.br
研究联系人备份
- 姓名：Jaomar JC Salazar, MD
- 电话号码：+5511966477244
- 邮箱：jaomar@usp.br
学习地点
-
-
São Paulo
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São Paulo、São Paulo、巴西、05403-900
- 招聘中
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
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接触：
- Marcelo BP Amato, MD PhD
- 电话号码：+55113061-7361
- 邮箱：marcelo.amato@hc.fm.usp.br
-
接触：
- Jaomar JC Salazar, MD
- 电话号码：+5511966477244
- 邮箱：jaomar@usp.br
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of perfusion maps obtained by Electrical Impedance Tomography (EIT) in the pre- and postoperative period using the wasted ventilation index..
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparison of pulmonary perfusion assessed by Electrical Impedance Tomography and SPECT-CT.
大体时间：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.
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of life assessed by SF-36 questionnaire after pulmonary thromboendarterectomy.
大体时间：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.
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年2月25日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年2月10日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月4日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.