About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Age under 18 years
Pregnancy
Structural heart disease (atrial septal defect, ventricular septal defect, or valvular heart disease)
Cardiac arrhythmias
Trial design
Single group
Treatments tested in this trial
Electrical Impedance Tomography (EIT).
Diagnostic testNon-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 SPECT-CT.
Diagnostic testPulmonary 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.
Procedure/SurgeryPulmonary 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Comparison of pulmonary perfusion assessed by Electrical Impedance Tomography and SPECT-CT.
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.
Incidence of adverse events related to Electrical Impedance Tomography perfusion assessment.
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.
Other outcomes
Quality of life assessed by SF-36 questionnaire after pulmonary thromboendarterectomy.
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.
Correlation between EIT-derived pulsatility and hemodynamic parameter.
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.
Change in plasma sodium concentration after hypertonic saline injection
Change in plasma sodium concentration measured before and after hypertonic saline injection used for Electrical Impedance Tomography perfusion assessment, expressed in mEq/L.
Sponsors and contacts
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