Bedside electrical imaging of lung blood flow during clot-removal surgery for CTEPH
Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.
We will test whether bedside electrical impedance tomography (EIT) can measure regional lung blood flow before and after pulmonary thromboendarterectomy in people with chronic thromboembolic pulmonary hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (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 | NCT07577700 on ClinicalTrials.gov |
What this trial studies
This prospective diagnostic protocol uses non-invasive, radiation-free electrical impedance tomography (EIT) to monitor regional pulmonary perfusion in the perioperative period of pulmonary thromboendarterectomy. EIT measurements will be taken before and after surgery and compared with standard perfusion SPECT/CT imaging. Quantitative indices derived from impedance pulsatility will be used to track perfusion changes associated with clot removal and hemodynamic improvement. The study focuses on feasibility and performance of EIT as a complementary bedside tool for monitoring perfusion in CTEPH patients.
Who should consider this trial
Good fit: Adults with chronic thromboembolic pulmonary hypertension who are scheduled for pulmonary thromboendarterectomy at the University of São Paulo Heart Institute (InCor) and who meet inclusion/exclusion criteria are ideal candidates.
Not a fit: Patients under 18, pregnant individuals, those with cardiac implantable electronic devices, significant arrhythmias, thoracic skin lesions at electrode sites, or who are not undergoing the planned surgery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, EIT could provide immediate bedside information on regional lung blood flow changes after thromboendarterectomy without ionizing radiation, aiding postoperative monitoring and management.
How similar studies have performed: Prior small studies and feasibility reports have demonstrated that EIT can track regional lung perfusion and pulsatility, but it remains less established than standard modalities like perfusion SPECT/CT.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) followed at the Pulmonology Service of InCor-HCFMUSP and scheduled for pulmonary thromboendarterectomy at InCor-FMUSP. Exclusion Criteria: * Age under 18 years * Pregnancy * Structural heart disease (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
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.