UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease

Accurate continuous hemodynamic monitoring is important in the management of pediatric and neonatal patients with congenital heart disease, but current monitoring methods may be invasive, intermittent, operator-dependent, or difficult to apply in small pediatric patients. UltraTrac is an investigational wearable hemodynamic monitoring device that integrates impedance cardiography and carotid Doppler ultrasound into a single noninvasive platform. The device uses surface electrodes on the thorax and a wearable Doppler probe positioned over the carotid artery. No vascular access, ionizing radiation, or invasive procedure is required for device application or operation. This prospective, single-center, pilot feasibility study will evaluate the accuracy and feasibility of UltraTrac for noninvasive cardiac output monitoring in patients with congenital heart disease across three clinical settings: the cardiac catheterization laboratory, the cardiac MRI suite, and the cardiac intensive care unit. In the cardiac catheterization laboratory arm, UltraTrac cardiac output measurements will be compared with thermodilution and/or direct Fick cardiac output measurements obtained during clinically indicated cardiac catheterization. In the cardiac MRI arm, UltraTrac measurements will be compared with cardiac MRI-derived cardiac output measurements obtained as part of clinically indicated imaging. In the cardiac intensive care unit arm, UltraTrac will be used to assess directional changes in cardiac output before and after clinically indicated introduction or titration of vasoactive medications. UltraTrac measurements will not be used to guide clinical care. All clinical decisions will remain the responsibility of the treating clinical team, and UltraTrac data will be analyzed offline after data collection.