Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.
4. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Marcelo BP Amato, MD PhD
- Telefonnummer: +55113061-7361
- E-post: marcelo.amato@hc.fm.usp.br
Studer Kontakt Backup
- Navn: Jaomar JC Salazar, MD
- Telefonnummer: +5511966477244
- E-post: jaomar@usp.br
Studiesteder
-
-
São Paulo
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São Paulo, São Paulo, Brasil, 05403-900
- Rekruttering
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
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Ta kontakt med:
- Marcelo BP Amato, MD PhD
- Telefonnummer: +55113061-7361
- E-post: marcelo.amato@hc.fm.usp.br
-
Ta kontakt med:
- Jaomar JC Salazar, MD
- Telefonnummer: +5511966477244
- E-post: jaomar@usp.br
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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..
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of pulmonary perfusion assessed by Electrical Impedance Tomography and SPECT-CT.
Tidsramme: 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.
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life assessed by SF-36 questionnaire after pulmonary thromboendarterectomy.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. februar 2025
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
10. februar 2026
Først innsendt som oppfylte QC-kriteriene
4. mai 2026
Først lagt ut (Faktiske)
11. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 78916224.4.0000.0068
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Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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