Caretaker Hemodynamic Parameters Validation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- CareTaker Medical LLC
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Cardiac output performance comparison
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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
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
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.