Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07577700

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

Led by University of Sao Paulo General Hospital · Updated on 2026-05-11

36

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic thromboembolic pulmonary hypertension (CTEPH) occurs when old blood clots block lung blood vessels, making it harder for the heart to pump blood. Pulmonary thromboendarterectomy is a surgery to remove these clots and improve lung blood flow. Researchers are evaluating a bedside imaging method called electrical impedance tomography (EIT) to measure lung blood flow before and after surgery without radiation or invasive procedures. The study aims to see if EIT can provide helpful information about lung blood flow changes and serve as a complementary monitoring tool for CTEPH patients. In this study, patients undergoing pulmonary thromboendarterectomy will be monitored using EIT before and after surgery. EIT measures lung blood flow by analyzing pulsatility signals and first-pass kinetics after a saline bolus, creating regional perfusion maps and quantitative indices such as the wasted ventilation index. These results will be compared with standard pulmonary perfusion imaging using SPECT-CT, performed before surgery and during follow-up. The surgery itself follows standard clinical practice and is not part of the study intervention. Participants will be assessed with EIT in the preoperative and immediate postoperative periods during their intensive care stay, and SPECT-CT scans will be done before surgery and up to six months after. Researchers will measure lung perfusion changes, compare imaging results, and monitor for any adverse events related to EIT. The main outcome is evaluating EIT perfusion maps from before surgery to the day of surgery postoperatively. The study includes clinical monitoring until hospital discharge and follow-up assessments for up to six months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) followed at the Pulmonology Service of InCor-HCFMUSP and scheduled for pulmonary thromboendarterectomy at InCor-FMUSP
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnancy
  • Structural heart disease such as 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week before surgery

Participants undergo preoperative diagnostic imaging assessments including Electrical Impedance Tomography (EIT) and pulmonary perfusion SPECT-CT to evaluate regional pulmonary perfusion before surgery.

1 to 2 visits depending on imaging schedules

Surgery and Immediate Post-operative Care

Duration - Surgery day and hospital stay up to approximately 30 days

Participants undergo pulmonary thromboendarterectomy surgery followed by monitoring in the intensive care unit where immediate postoperative EIT measurements are performed to assess pulmonary perfusion changes.

Daily assessments during hospital stay

Post-operative Follow-up

Duration - Up to 6 months after surgery

Participants have follow-up pulmonary perfusion assessments using EIT and SPECT-CT imaging to monitor recovery and compare perfusion changes up to 6 months after surgery.

Approximately 3 to 4 follow-up visits

Trial Site Locations

Total: 1 location

1

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

São Paulo, São Paulo, Brazil, 05403-900

Actively Recruiting

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Research Team

M

Marcelo BP Amato, MD PhD

J

Jaomar JC Salazar, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Pulmonary perfusion and ventricular ejection imaging by frequency domain filtering of EIT (electrical impedance tomography) images.

M Zadehkoochak, B H Blott, T K Hames...

https://pubmed.ncbi.nlm.nih.gov/1587100

Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding.

Irene M Lang, Raffaele Pesavento, Diana Bonderman...

https://pubmed.ncbi.nlm.nih.gov/22700839

Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism.

L Guérin, F Couturaud, F Parent...

https://pubmed.ncbi.nlm.nih.gov/24898545