Caretaker Hemodynamic Parameters Validation

NCT ID: NCT04685733

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings, continuous beat-by-beat left ventricular ejection times (LVET) against matching LVETs obtained from central catheters, cardiac output (CO) and stroke volume (SV) measures against thermo-dilution and Fick measurements, and standard HRV parameters based on Caretaker-provided inter-beat intervals (IBI) against the same HRV parameters obtained from ECG-based IBIs.

Conditions

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Blood Pressure Cardiac Output Left Ventricular Ejection Time Heart Rate Variability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Comparison of blood pressure, LVET and CO/SV measures with respective Gold Standards

Non-invasive hemodynamic measurements

Intervention Type DEVICE

Non-invasive hemodynamic measurements

Group 2

Comparison of blood pressure and HRV measures with respective Gold Standards

Non-invasive hemodynamic measurements

Intervention Type DEVICE

Non-invasive hemodynamic measurements

Group 3

Comparison of blood pressure and CO/SV measures with respective Gold Standards

Non-invasive hemodynamic measurements

Intervention Type DEVICE

Non-invasive hemodynamic measurements

Interventions

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Non-invasive hemodynamic measurements

Non-invasive hemodynamic measurements

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age, who are able and willing to participate and have given written assent

Exclusion Criteria

* Unable to give written assent

* \<18 years of age
* No or poor finger pulse, as determined through visual inspection for ischemic hands
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Orange County Research Center

OTHER

Sponsor Role collaborator

CareTaker Medical LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Baruch, PhD

Role: PRINCIPAL_INVESTIGATOR

Caretaker Medical

Locations

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Caretaker Medical

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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Hemo_001

Identifier Type: -

Identifier Source: org_study_id