UltraTrac Clinical Pilot Study

This study is a single center, single group pilot study designed to assess the accuracy and feasibility of non invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard of care diagnostic cardiac catheterization. The UltraTrac system integrates ultrasound technology with a previously FDA 510(k)-cleared impedance cardiography (ICG) technology to provide noninvasive hemodynamic monitoring. Integrating the information obtained from ultrasound with ICG technology will allow for an accurate fine tuning of stroke volume measurements with an ongoing monitoring of hemodynamics. During the catheterization procedure, trained study personnel will apply four single use surface-skin electrodes and a Doppler ultrasound probe secured with an adhesive patch. The ultrasound probe is used for audio only signal of flow in the carotid artery, and measurements will be performed only when the participant is hemodynamically stable and the standard of care procedure allows, as judged by the physician in charge. UltraTrac measurements take approximately 15 minutes including setup, and at least five cardiac output measurements will be collected for each participant. The primary objective is to determine accuracy of algorithm derived stroke volume and cardiac output data by comparison with standard measurement methods in the cardiac catheterization laboratory (Fick measurement or thermodilution). The primary endpoint is concordance between algorithm derived measurements and standard measurements. The secondary objective is to determine human factors associated with use of the device in the clinical setting, assessed through clinician reported usability issues. The study will enroll 50 pediatric participants, with up to 60 screened to account for screen failures. Eligible participants must be scheduled for diagnostic cardiac catheterization and be hemodynamically stable, with exclusions for weight \<2.5 kg, broken skin, or moderate to severe reactions to ECG adhesives or ultrasound gel. The protocol describes UltraTrac as non significant risk, noting that it is noninvasive, not implanted, and does not pose a serious risk to the health, safety, or welfare of the subject. Risks are limited to possible skin irritation or infection from the placement of the electrodes and the Doppler probe, and there are no known direct benefits to participants. UltraTrac measurements will not be used to inform care. All adverse events will be collected and monitored according to good clinical practices and institutional policies. The study duration is 1 year, and participant involvement is one day, corresponding to the catheterization procedure. Data will be exported and analyzed to determine the feasibility and accuracy of UltraTrac as a noninvasive method for pediatric cardiac output assessment.