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Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References

Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05035719
Enrollment
60
Registered
2021-09-05
Start date
2021-03-01
Completion date
2022-03-31
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output, Low

Brief summary

Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Detailed description

Comparison study comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references. Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements

Interventions

DEVICEnon-invasive cardiac output monitor

Equivalence of Caretaker cardiac output reading to reference standard

Sponsors

The Cooper Health System
CollaboratorOTHER
CareTaker Medical LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years of age * able and willing to participate * provide written consent

Exclusion criteria

* Unable to give written consent * \<18 years of age * No or poor finger pulse, as determined through visual inspection for ischemic hands

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output performance comparisonChange between several paired readings over the course of cardiac surgery (typically 2-4 hours)Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.

Countries

United States

Contacts

Primary ContactMartin C Baruch, PhD
martin@caretakermedical.net434 978-7000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026