Testing a skin-sensor device that measures heart output in children having heart catheterization
Compares UltraTrac heart output readings with standard measurements in children undergoing cardiac catheterization.
Plain-language title generated from the registry record
Registry title: UltraTrac Clinical Pilot Study
Key facts
- Where
- Washington D.C., United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 21 years old?
Source: NCT07864714, who can take part
Where in United States
- Children's National HospitalWashington D.C., United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AcQumen Medical, Inc.
- Trial code
- NCT07864714
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
Clinical Pilot Study of UltraTrac-determined Cardiac Output With Standard Measures of Cardiac Output
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.
Inclusion: Provision of signed and dated parental permission form (for patients <18) or informed consent form (for patients >= 18 years); Provision of verbal (for patients 7-11) or signed and dated assent form (for patients 12-17); Stated willingness to comply with all study procedures; Male or female, aged 0 - 21 years; Scheduled to undergo standard of care diagnostic cardiac catheterization at Children's National Hospital.
Exclusion: Weight less than 2.5kg; Patients who are hemodynamically unstable, as assessed by the attending physician; Broken skin or poor skin integrity that would prohibit safe adhesion of electrodes or Doppler probe; Known moderate-to-severe reactions to electrocardiogram electrode adhesives or ultrasound gel.