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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

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 volunteers

Qualifiers

None

Disqualifiers

Age under 18 years

Pregnancy

Structural heart disease (atrial septal defect, ventricular septal defect, or valvular heart disease)

Cardiac arrhythmias

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • Pulmonary Thromboendarterectomy.

    Procedure/Surgery

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Diagnostic Imaging Ar.Experimental treatment 3 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From the preoperative period to the postoperative follow-up (up to 6 months after surgery).
2

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.

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

Other outcomes

1

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.

Time frame
Up to 6 months after surgery.
2

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.

Time frame
From the preoperative period to the immediate postoperative period (during intensive care unit stay).
3

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.

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

Sponsors and contacts

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