Caretaker Hemodynamic Parameters Validation

NCT04685733 | Completed FDA Device

• 1 other identifier: Hemo_001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Pressure; Cardiac Output; Left Ventricular Ejection Time; Heart Rate Variability

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Group 1

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

Device: Non-invasive hemodynamic measurements

Group 2

Comparison of blood pressure and HRV measures with respective Gold Standards

Device: Non-invasive hemodynamic measurements

Group 3

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

Device: Non-invasive hemodynamic measurements

Interventions

Non-invasive hemodynamic measurements DEVICE

Non-invasive hemodynamic measurements

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CareTaker Medical LLC: lead
• University of Virginia: collaborator
• Yale University: collaborator
• Orange County Research Center: collaborator

Study Sites (1)

Caretaker Medical

Charlottesville, Virginia, 22901, United States

Location

Study Officials

• Martin Baruch, PhD

  Caretaker Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: February 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

US (1)