Caretaker Hemodynamic Parameters Validation

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Heart Rate Variability; Cardiac Output; Left Ventricular Ejection Time
• Intervention / Treatment: Device: Non-invasive hemodynamic measurements

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Caretaker Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be patients, > 18 years of age, who are able and willing to participate and have given written assent

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Comparison of blood pressure, LVET and CO/SV measures with respective Gold Standards	Device: Non-invasive hemodynamic measurements; Non-invasive hemodynamic measurements
Group 2; Comparison of blood pressure and HRV measures with respective Gold Standards	Device: Non-invasive hemodynamic measurements; Non-invasive hemodynamic measurements
Group 3; Comparison of blood pressure and CO/SV measures with respective Gold Standards	Device: Non-invasive hemodynamic measurements; Non-invasive hemodynamic measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure performance comparison	Comparison with arterial catheter-derived blood pressure, guidelines call for meeting a bias of 5 mmHg and a standard deviation of 8 mmHg	Paired beat-by-beat readings over maximum of 2.5 hours session length
Cardiac output performance comparison	Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.	Paired measurements over approximately 1 hour time frame
Left ventricular ejection time comparison	Comparison with LVET derived from central catheter signal traces, agreement within 20 msec.	Paired measurements over approximately 1 hour time frame
Heart rate variability measures comparison	Comparison with 5 HRV ECG-derived measures, agreement within performance of VitalConnect predicate device	Paired beat-by-beat readings over maximum of 2.5 hours session length

Collaborators and Investigators

• Sponsor: CareTaker Medical LLC
• Collaborators: University of Virginia; Yale School of Medicine; Orange County Research Center
• Investigators: Principal Investigator: Martin Baruch, PhD, Caretaker Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Hemo_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No