Using bedside electrical impedance tomography to detect pulmonary hypertension
Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization
We will test whether a non-invasive bedside scan called electrical impedance tomography (EIT) can detect pulmonary hypertension in adults who are already having a right heart catheterization.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07453017 on ClinicalTrials.gov |
What this trial studies
This single-center prospective diagnostic study will enroll adults referred for right heart catheterization for suspected or staged pulmonary arterial hypertension. Participants will undergo standard invasive hemodynamic measurement by right heart catheterization followed by short-term EIT monitoring at the bedside, with some subjects receiving a hypertonic saline bolus during a brief respiratory pause to enhance perfusion signal. EIT recordings will be processed offline with algorithms that separate ventilation and perfusion and extract pulsatility-related parameters, which will be compared to invasive measures such as mean pulmonary artery pressure, pulmonary vascular resistance, cardiac output, and stroke volume. The primary goal is to determine how accurately EIT can detect pulmonary hypertension and to explore perfusion/pulsatility indices and diagnostic thresholds for disease severity.
Who should consider this trial
Good fit: Adults with suspected or confirmed pulmonary arterial hypertension who have a clinical indication for right heart catheterization and can tolerate a brief respiratory pause are ideal candidates.
Not a fit: Patients with structural heart defects, cardiac arrhythmias, implantable electronic devices, thoracic skin lesions, pregnancy, WHO functional class IV, or inability to perform the required respiratory pause may not benefit or will be excluded.
Why it matters
Potential benefit: If successful, EIT could offer a safe, radiation-free bedside screening tool that helps detect or monitor pulmonary hypertension and reduce reliance on invasive right heart catheterization.
How similar studies have performed: Small pilot studies and growing EIT research have shown promise for imaging pulmonary perfusion, but using EIT as a diagnostic alternative to right heart catheterization for pulmonary hypertension remains novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis or clinical suspicion of pulmonary arterial hypertension (PAH) and with a medical indication for right heart catheterization. * Patients evaluated at the Pulmonology Service of InCor-HCFMUSP. Exclusion Criteria: * Pregnancy. * Structural heart disease, such as atrial septal defect, ventricular septal defect, or valvular disease. * Cardiac arrhythmias. * Presence of a cardiac pacemaker or other implantable electronic device. * Skin lesions at the thoracic region that would prevent placement of the EIT electrode belt. * WHO functional class IV of new york heart association (NYAH).. * Inability to perform a voluntary respiratory pause (apnea) of at least 30 seconds or inability to understand and follow instructions required. * Decline to participate in the study by not signing the informed consent form or refusal by the attending medical team.
Where this trial is running
São Paulo, São Paulo
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Marcelo BP Amato, MD PhD
- Email: marcelo.amato@hc.fm.usp.br
- Phone: +55113061-7361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.