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OpenTrials
Completed

NCT Number: NCT04685733

Caretaker Hemodynamic Parameters Validation

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

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Key information

Conditions

Blood Pressure Cardiac Output Heart Rate Variability Left Ventricular Ejection Time

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caretaker Medical

Charlottesville, Virginia, 22901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive hemodynamic measurements

Device

Non-invasive hemodynamic measurements

Primary outcomes

  1. Blood pressure performance comparison

    Time frame: Paired beat-by-beat readings over maximum of 2.5 hours session length

    Comparison with arterial catheter-derived blood pressure, guidelines call for meeting a bias of 5 mmHg and a standard deviation of 8 mmHg

  2. Cardiac output performance comparison

    Time frame: Paired measurements over approximately 1 hour time frame

    Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.

  3. Left ventricular ejection time comparison

    Time frame: Paired measurements over approximately 1 hour time frame

    Comparison with LVET derived from central catheter signal traces, agreement within 20 msec.

  4. Heart rate variability measures comparison

    Time frame: Paired beat-by-beat readings over maximum of 2.5 hours session length

    Comparison with 5 HRV ECG-derived measures, agreement within performance of VitalConnect predicate device

Sponsors and collaborators

Lead sponsor

CareTaker Medical LLC

Industry

Collaborators

  • Orange County Research Center
  • University of Virginia
  • Yale University

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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