AcQumen Medical, Inc.
This single-center pilot study will evaluate 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. UltraTrac integrates ultrasound with impedance cardiography (ICG) to refine stroke volume and cardiac output calculations. During catheterization, trained staff will apply four surface-skin electrodes and a Doppler probe and obtain UltraTrac measurements without altering standard clinical care. The primary objective is to assess concordance between algorithm-derived cardiac output and gold-standard invasive measurements (Fick or thermodilution). The secondary objective is to evaluate human-factors issues reported by clinicians during device use. The study will enroll 50 hemodynamically stable pediatric participants, with up to 60 screened to account for screen failures. UltraTrac poses no more than minimal risk, using noninvasive sensors comparable to standard electrocardiogram (ECG) and Doppler procedures. Measurements will be performed only when clinically appropriate, and no UltraTrac data will be used to guide patient care.
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…
Inclusion Criteria: 1. Provision of signed and dated parental permission form (for patients \<18) or informed consent form (for patients \>= 18 years) 2. Provision of verbal (for patients 7-11) or signed and dated assent form (for patients 12-17) 3. Stated willingness to comply with all study procedures 4. Male or female, aged 0 - 21 years 5. Scheduled to undergo standard of care diagnostic cardiac catheterization at Children's National Hospital Exclusion Criteria: 1. Weight less than 2.5kg 2. Patients who are hemodynamically unstable, as assessed by the attending physician 3. Broken skin o…
This study involves the use of a noninvasive hemodynamic monitoring system that integrates impedance cardiography with Doppler ultrasound to measure cardiac function. The system uses standard adhesive electrodes placed on the skin and a small ultrasound sensor positioned over the carotid artery. During each measurement period, the system collects impedance waveforms and ultrasound timing signals to estimate stroke volume, cardiac output, and left ventricular ejection time. The UltraTrac is used only for physiologic monitoring and data collection. Study data are not used to deliver therapy, influence clinical care, or provide diagnostic information to participants or clinicians.
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