RecruitingNot ApplicableNCT07577700

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


Sponsor

University of Sao Paulo General Hospital

Enrollment

36 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • \- 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 Criteria10

  • 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

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Interventions

DIAGNOSTIC_TESTElectrical Impedance Tomography (EIT).

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_TESTPulmonary Perfusion SPECT-CT.

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.

PROCEDUREPulmonary Thromboendarterectomy.

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.


Locations(1)

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

São Paulo, São Paulo, Brazil

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NCT07577700


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