This study will test the use of the UltraTrac™ system, a small, noninvasive device that uses electrodes on the skin and a small ultrasound sensor to provide measurements of cardiac function in a wide of subjects. UltraTrac estimates cardiac output and other hemodynamic parameters without needles or invasive procedures.
Up to 400 generally healthy volunteers, from infants to older adults, will take part in a single study visit lasting about one hour. During the visit, study staff place small adhesive electrodes on the skin and a lightweight ultrasound sensor on the neck or thigh. The device records heart-related signals while the participant is lying down, sitting, and during simple movements such as repositioning, passive leg raise, or light exercise (like walking or pedaling in place). The study evaluates how often the UltraTrac device can collect good-quality signals and how consistent the measurements are across different ages and activity levels.
There is no direct medical benefit to participants. The risks are minimal, such as mild skin irritation from adhesive electrodes. The information collected will help improve the UltraTrac system and support future regulatory review so that noninvasive cardiac monitoring may become more widely available, especially for children and other patients who are not able to undergo invasive monitoring.
Age 2 months to 95 years of age, of varying racial origins, and with or without cardiovascular or pulmonary disease.
Generally healthy, as confirmed by verbal health history at screening.
Parent or legal guardian provides written informed consent; subject provides assent where applicable and appropriate.
Subject and parent/guardian are able to understand and comply with study procedures.
Participants who have had admission or a visit to an emergency room or hospital admission for a cardiovascular or pulmonary illness such as congestive heart failure or asthma, within the prior 30 days will be excluded.
Females if lactating or pregnant, or if childbearing potential and without use of standard birth control, will be excluded.
Active skin condition, injury, rash, or dermatitis in areas of planned electrode or ultrasound probe placement.
Known latex or adhesive sensitivity or sensitivity to hydrogel or ultrasound coupling gel.
This study will enroll up to 400 volunteer participants ranging from 2 months to 95 years of age, representing a broad cross-section of the general population. Subjects must be generally healthy, as determined by verbal health history, and have had no hospitalizations or emergency care visits for cardiopulmonary conditions within the preceding 30 days. Participants may include individuals with or without stable cardiovascular or pulmonary conditions, provided they meet all inclusion criteria and have no active illness. Enrollment will include diverse racial and ethnic backgrounds and both pediatric and adult age groups. Subjects must be able to understand and comply with study procedures, and for minors, parental permission and age-appropriate assent are required. Individuals with pregnancy, lactation, active skin conditions at electrode placement sites, or known sensitivities to adhesives, hydrogel, or ultrasound gel will be excluded.
Cohort
Prospective
Noninvasive Hemodynamic Monitoring System
DeviceThis 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 or femoral 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. Data are recorded while participants are at rest and during simple movement conditions to evaluate signal acquisition quality, measurement precision, and device performance. 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.
Rate of successful waveform acquisition and adequate signal to noise characteristics
Successful ICG waveform acquisition rate as determined by counts and proportions of subjects; adequate ultrasound signal strength summarized descriptively; adequate ICG and ultrasound signal to noise characteristics summarized descriptively
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