NCT07864714Not yet recruiting
UltraTrac Clinical Pilot Study
Clinical Pilot Study of UltraTrac-determined Cardiac Output With Standard Measures of Cardiac Output
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- AcQumen Medical, Inc.
- Diseases
- Stroke
- NCT number
- NCT07864714
What you commit to
- Study type: Observational
- Planned participants: 50
- From Oct 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 0 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.