[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659540":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":27,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":11,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"AcQumen Medical, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Concordance between algorithm-derived measurements and standard measurements.",null,"Periprocedural",[14],{"measure":15,"description":16,"timeFrame":12},"Study staff and physician procedural issues captured via structured reporting form","Qualitative and quantitative documentation of issues encountered during the procedure, including number and type of issue, collected through a structured reporting form completed by study staff and physicians.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":18,"timePerspective":19,"maskingInfo":11},"COHORT","PROSPECTIVE","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.\n\nDuring 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.\n\nThe 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.\n\nThe 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 \\\u003C2.5 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.\n\nRisks 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.\n\nThe 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.","Pediatric patients aged 0-21 years who are hemodynamically stable and undergoing cardiac catheterization as part of standard of care at Children's National Hospital in Washington, DC.",[23],{"label":24,"type":11,"description":21,"interventionNames":25},"Pediatric patients indicated for diagnostic cardiac catheterization",[26],"Device: Noninvasive Hemodynamic Monitoring System",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","Noninvasive Hemodynamic Monitoring System","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.\n\nThe 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.",[24],[34,35],"UltraTrac","Impedance Cardiography",[37],{"name":38,"affiliation":39,"role":40},"Joshua P Kanter, MD, FACC","Children's National Research Institute","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Dori R Jones, MSE","CONTACT","866-227-8636","djones@acqumenmedical.com",[48],{"facility":49,"status":11,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":11},"Children's National Hospital","Washington D.C.","District of Columbia","20010","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-77.03637,38.89511,{"lat":59,"lon":58},{"type":62,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[64],{"name":39,"class":65},"OTHER","100659540","ultratrac-clinical-pilot-study-100659540",false,"NCT07864714","UltraTrac Clinical Pilot Study","Clinical Pilot Study of UltraTrac-determined Cardiac Output With Standard Measures of Cardiac Output","ULTRA-CO","Inclusion Criteria:\n\n1. Provision of signed and dated parental permission form (for patients \\\u003C18) or informed consent form (for patients \\>= 18 years)\n2. Provision of verbal (for patients 7-11) or signed and dated assent form (for patients 12-17)\n3. Stated willingness to comply with all study procedures\n4. Male or female, aged 0 - 21 years\n5. Scheduled to undergo standard of care diagnostic cardiac catheterization at Children's National Hospital\n\nExclusion Criteria:\n\n1. Weight less than 2.5kg\n2. Patients who are hemodynamically unstable, as assessed by the attending physician\n3. Broken skin or poor skin integrity that would prohibit safe adhesion of electrodes or Doppler probe\n4. Known moderate-to-severe reactions to electrocardiogram electrode adhesives or ultrasound gel","ALL","0 Years","21 Years",{"count":78,"type":79},50,"ESTIMATED","OBSERVATIONAL","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.",[83],"Hemodynamic Monitoring",[85,86,87,88,35,89,90,91],"hemodynamics","Cardiovascular Physiology","Cardiac Output","Stroke Volume","Pediatric Monitoring","Ultrasonography, Doppler","Signal Processing","NOT_YET_RECRUITING","2026-10-02",{"date":95,"type":96},"2026-10-08","ACTUAL",{"date":98,"type":79},"2026-10",{"date":100,"type":79},"2027-10",{"name":5,"class":6},1]