Caretaker Hemodynamic Parameters Validation

Completed

• Conditions: Blood Pressure; Heart Rate Variability; Left Ventricular Ejection Time; Cardiac Output
• Interventions: Device: Non-invasive hemodynamic measurements

• Registration Number: NCT04685733
• Lead Sponsor: CareTaker Medical LLC

Brief Summary

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

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 Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-12
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-24
• Last Update Submitted: 2020-12-24
• Study First Posted: 2020-12-28
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cardiac output performance comparison	Paired measurements over approximately 1 hour time frame	Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.
Heart rate variability measures comparison	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
Blood pressure performance comparison	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
Left ventricular ejection time comparison	Paired measurements over approximately 1 hour time frame	Comparison with LVET derived from central catheter signal traces, agreement within 20 msec.

Trial Locations

Locations (1)

Caretaker Medical; 🇺🇸 Charlottesville, Virginia, United States