RecruitingNot ApplicableNCT07453017

Electrical Impedance Tomography for Assessment of Pulmonary Hypertension

Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization


Sponsor

University of Sao Paulo General Hospital

Enrollment

120 participants

Start Date

Apr 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Pulmonary hypertension is a serious and progressive disease that is difficult to treat and diagnose, mainly because its symptoms are nonspecific and often delay recognition. Early diagnosis is a major challenge. Although several tests may suggest the disease, the definitive diagnosis still requires right heart catheterization, an invasive procedure that directly measures pulmonary hemodynamics such as pulmonary artery pressure, cardiac output, and vascular resistance. Electrical impedance tomography (EIT) is a non-invasive, radiation-free bedside monitoring method that can evaluate ventilation and pulmonary perfusion. The number of studies investigating perfusion with EIT has been increasing, since the possibility of having a safe, radiation-free, and repeatable method available at the bedside is of great clinical interest in different fields of medicine. Our hypothesis is that EIT provides information that correlates with the findings of right heart catheterization in patients with suspected pulmonary arterial hypertension (PAH). EIT may serve as a useful screening tool prior to catheterization and may also help in risk stratification of patients with pulmonary hypertension


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a non-invasive imaging method called electrical impedance tomography (EIT)—which uses a sensor belt around the chest to measure how air moves through the lungs—can help assess pulmonary arterial hypertension (PAH), a condition where blood pressure in the lung arteries is dangerously high. This could offer a safer alternative to existing tests. **You may be eligible if...** - You have been diagnosed with or are suspected of having pulmonary arterial hypertension (high blood pressure in the lungs) - You are already scheduled to have a right heart catheterization (a standard diagnostic procedure for this condition) at InCor-HCFMUSP in Brazil **You may NOT be eligible if...** - You are pregnant - You have structural heart defects (like a hole in the heart) or heart valve disease - You have a cardiac arrhythmia (irregular heartbeat) or a pacemaker/implanted device - You have skin lesions on your chest that prevent placement of the sensor belt - You are in the most severe class of heart failure (WHO Class IV) - You cannot hold your breath for at least 30 seconds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTElectrical Impedance Tomography (EIT)

Non-invasive, radiation-free bedside monitoring of ventilation and pulmonary perfusion. Patients will be monitored for a short period using EIT, with data analyzed offline to assess pulsatility and perfusion indices.

PROCEDURERight Heart Catheterization

Standard invasive hemodynamic assessment performed for clinical indication, including measurement of pulmonary artery pressure, cardiac output, pulmonary vascular resistance, and stroke volume. Used as the gold standard comparator for EIT-derived measures.


Locations(1)

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

São Paulo, São Paulo, Brazil

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NCT07453017


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