UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease (UltraTrac)
UltraTrac for Noninvasive Cardiac Output Monitoring in Patients With Congenital Heart Disease: A Multi-Setting Pilot Feasibility Study
This pilot feasibility study will evaluate UltraTrac, an investigational noninvasive wearable device for continuous cardiac output monitoring, in patients with congenital heart disease.
UltraTrac integrates impedance cardiography and carotid Doppler ultrasound to estimate cardiac output. Participants undergoing clinically indicated cardiac catheterization, cardiac MRI, or cardiac intensive care unit monitoring will have UltraTrac measurements collected during routine clinical care.
UltraTrac measurements will be compared with reference standard or clinical hemodynamic measurements, including thermodilution, direct Fick method, cardiac magnetic resonance imaging-derived cardiac output, and clinical hemodynamic assessments before and after vasoactive medication changes. UltraTrac data will not be used to guide clinical decision-making.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Accurate continuous hemodynamic monitoring is important in the management of pediatric and neonatal patients with congenital heart disease, but current monitoring methods may be invasive, intermittent, operator-dependent, or difficult to apply in small pediatric patients.
UltraTrac is an investigational wearable hemodynamic monitoring device that integrates impedance cardiography and carotid Doppler ultrasound into a single noninvasive platform. The device uses surface electrodes on the thorax and a wearable Doppler probe positioned over the carotid artery. No vascular access, ionizing radiation, or invasive procedure is required for device application or operation.
This prospective, single-center, pilot feasibility study will evaluate the accuracy and feasibility of UltraTrac for noninvasive cardiac output monitoring in patients with congenital heart disease across three clinical settings: the cardiac catheterization laboratory, the cardiac MRI suite, and the cardiac intensive care unit.
In the cardiac catheterization laboratory arm, UltraTrac cardiac output measurements will be compared with thermodilution and/or direct Fick cardiac output measurements obtained during clinically indicated cardiac catheterization. In the cardiac MRI arm, UltraTrac measurements will be compared with cardiac MRI-derived cardiac output measurements obtained as part of clinically indicated imaging. In the cardiac intensive care unit arm, UltraTrac will be used to assess directional changes in cardiac output before and after clinically indicated introduction or titration of vasoactive medications.
UltraTrac measurements will not be used to guide clinical care. All clinical decisions will remain the responsibility of the treating clinical team, and UltraTrac data will be analyzed offline after data collection.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Brittany Faanes
- Telefonnummer: 612-625-5929
- E-Mail: grego318@umn.edu
Studienorte
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55454
- M Health Fairview University of Minnesota Masonic Children's Hospital
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Kontakt:
- Juan Carlos Samayoa
- E-Mail: samay008@umn.edu
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 0-80 years old
- Participant weight of at least 2 kg
- Diagnosis of congenital heart disease of any anatomic type, including but not limited to repaired or unrepaired single ventricle physiology, biventricular congenital heart disease, valvular disease, septal defects, and conotruncal anomalies
- Clinically indicated cardiac catheterization, cardiac MRI, or cardiac intensive care unit admission during the study enrollment period
- For Arm 1: scheduled to undergo hemodynamic cardiac catheterization during which thermodilution and/or direct Fick cardiac output measurements will be performed as part of standard clinical care
- For Arm 2: scheduled to undergo cardiac MRI during which CMR-derived cardiac output measurement will be obtained as part of the clinical protocol
- For Arm 3: admitted to the cardiac intensive care unit and anticipated to require initiation or titration of vasoactive medication as part of standard clinical management
- Parental permission, and assent when applicable, obtained from at least one parent or legally authorized representative
Exclusion Criteria:
- Known allergy or prior skin reaction to adhesive electrodes or ultrasound gel
- Skin breakdown, wound, or infection at any proposed electrode or probe placement site that would preclude safe device application
- Hemodynamic instability at the time of enrollment that, in the judgment of the treating clinician, would preclude safe participation in research procedures
- Known carotid artery abnormality, prior carotid surgery, or anatomic variant that would preclude reliable carotid Doppler signal acquisition
- Participant or family refusal to participate or inability to obtain informed consent or parental permission
- Pregnant women/persons
- Fetuses
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Employees of the researcher
- Students of the researcher
- Active members of the military or DoD personnel
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Cardiac Catheterization Laboratory UltraTrac Monitoring
Participants undergoing clinically indicated cardiac catheterization will have UltraTrac measurements obtained and compared with thermodilution and/or direct Fick cardiac output measurements obtained as part of standard clinical care. |
UltraTrac is an investigational wearable hemodynamic monitoring device that integrates impedance cardiography and carotid Doppler ultrasound into a single noninvasive platform. In this study, UltraTrac will be used only as an observational monitoring device. UltraTrac measurements will not guide clinical decision-making, and all clinical management will proceed according to standard of care.
Andere Namen:
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Experimental: Cardiac MRI UltraTrac Monitoring
Participants undergoing clinically indicated cardiac MRI will have UltraTrac measurements obtained near the time of cardiac MRI and compared with CMR-derived cardiac output measurements obtained as part of standard clinical care. |
UltraTrac is an investigational wearable hemodynamic monitoring device that integrates impedance cardiography and carotid Doppler ultrasound into a single noninvasive platform. In this study, UltraTrac will be used only as an observational monitoring device. UltraTrac measurements will not guide clinical decision-making, and all clinical management will proceed according to standard of care.
Andere Namen:
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Experimental: Cardiac Intensive Care Unit UltraTrac Monitoring
Participants admitted to the cardiac intensive care unit will have UltraTrac measurements obtained before and after clinically indicated introduction or titration of vasoactive medications. UltraTrac trending will be compared with concurrent clinical hemodynamic assessments. |
UltraTrac is an investigational wearable hemodynamic monitoring device that integrates impedance cardiography and carotid Doppler ultrasound into a single noninvasive platform. In this study, UltraTrac will be used only as an observational monitoring device. UltraTrac measurements will not guide clinical decision-making, and all clinical management will proceed according to standard of care.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Agreement Between UltraTrac-Derived Cardiac Output and Reference Standard Cardiac Output During Cardiac Catheterization
Zeitfenster: Periprocedural cardiac catheterization
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Agreement between cardiac output measurements obtained periprocedural by UltraTrac and cardiac output measurements obtained by thermodilution and/or direct Fick method during clinically indicated cardiac catheterization will be assessed using Bland-Altman analysis. Percentage error will be calculated as two standard deviations of the bias divided by the mean cardiac output of the two methods. A percentage error of 30% or less will be considered clinically acceptable agreement. |
Periprocedural cardiac catheterization
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Agreement Between UltraTrac-Derived Cardiac Output and CMR-Derived Cardiac Output
Zeitfenster: Periprocedural cardiac MRI encounter
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Periprocedural agreement between UltraTrac-derived and CMR-derived cardiac output (L/min) and cardiac index (L/min/m²) will be assessed using Bland-Altman analysis. CMR-derived cardiac output will be obtained during clinically indicated cardiac MRI using phase contrast flow measurement and volumetric assessment. Each participant will contribute one measurement pair per encounter, consisting of one CMR-derived cardiac output value and the temporally closest UltraTrac-derived measurement. Reported parameters will include mean bias, limits of agreement, percentage error, and 95% confidence intervals for the bias and limits of agreement. Percentage error will be calculated as 2 standard deviations of the bias divided by the mean cardiac output of the two methods × 100. Percentage error ≤30% will indicate clinically acceptable agreement by Critchley and Critchley criteria. Results will be reported overall and by age group, weight category, and cardiac anatomy. |
Periprocedural cardiac MRI encounter
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Concordance Rate Between UltraTrac-Derived Directional Cardiac Output Changes and Clinical Hemodynamic Assessment in the CICU
Zeitfenster: Baseline and periprocedure up to 72 hrs post procedure.
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The ability of UltraTrac to detect directional changes in cardiac output will be assessed during the immediate postoperative period and throughout the broader CICU admission. Measurements will be obtained during pre-defined windows before and after each clinically indicated vasoactive medication initiation or titration event. The composite clinical reference standard will include heart rate, arterial blood pressure, capillary refill time, acid-base status and lactate, and invasive hemodynamic parameters where available (arterial line, central venous pressure). Concordance between UltraTrac-derived directional cardiac output changes and composite clinical hemodynamic assessment will be reported as a concordance rate (%). The specific statistical method for concordance analysis will be determined and pre-specified prior to data collection and will be detailed in the statistical analysis plan. |
Baseline and periprocedure up to 72 hrs post procedure.
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Percentage of Participants With Successful UltraTrac Device Placement and Analyzable Waveform Acquisition
Zeitfenster: Baseline and periprocedural
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Feasibility of UltraTrac device placement and signal acquisition will be assessed as the proportion of enrolled participants with successful device placement and analyzable waveform data acquisition across the cardiac catheterization laboratory, cardiac MRI suite, and cardiac intensive care unit settings. |
Baseline and periprocedural
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Time Required for UltraTrac Device Application
Zeitfenster: Baseline and periprocedural
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Time required for UltraTrac device application will be recorded by study personnel during the specific clinical setting in which the device is applied. |
Baseline and periprocedural
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UltraTrac Tolerability and Comfort Questionnaire Score
Zeitfenster: Baseline and periprocedural
|
Comfort and tolerability of device application will be assessed using the UltraTrac Tolerability and Comfort Questionnaire, a standardized instrument developed and defined prospectively by the study team prior to data collection. The questionnaire uses a 5-point rating scale ranging from 1 (minimum, very uncomfortable or intolerable) to 5 (maximum, completely comfortable and well tolerated), where higher scores indicate a better outcome. The questionnaire will be administered to the participant, caregiver, or both at the time of device removal following each study encounter. Mean scores and standard deviations will be reported for the overall cohort and stratified by age group, clinical setting, and device application duration. |
Baseline and periprocedural
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UltraTrac Waveform Signal Quality Scale Score
Zeitfenster: Baseline and periprocedural
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Signal quality will be assessed using the UltraTrac Waveform Signal Quality Scale, a standardized 5-point rating scale ranging from 1 (minimum, uninterpretable waveform) to 5 (maximum, optimal waveform quality), where higher scores indicate a better outcome. This scale was developed and defined prospectively by the study team prior to data collection. Scores will be assigned independently to ICG and carotid Doppler waveform acquisitions by two blinded reviewers. Mean scores and standard deviations will be reported for the overall cohort and across the following pre-specified subgroups: age (neonates 0-30 days, infants 31 days-12 months, children 1-12 years, adolescents and young adults 13-21 years, and adults 22 years and older), weight (<3 kg, 3-10 kg, 10-20 kg, >20 kg), and cardiac anatomy (single ventricle vs. biventricular). Inter-rater agreement will be reported using intraclass correlation coefficient. |
Baseline and periprocedural
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Juan Carlos Samayoa, University of Minnesota
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PEDS-2026-34943
- STUDY00028830 (Andere Kennung: University of Minnesota-IRB)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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