Caretaker Hemodynamic Parameters Validation

Study Overview
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Brief Summary
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Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Detailed Description
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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.

Official Title
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Caretaker Hemodynamic Parameters Validation

Conditions
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Blood Pressure, Cardiac Output, Left Ventricular Ejection Time, Heart Rate Variability

Intervention / Treatment
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* Device: Non-invasive hemodynamic measurements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Comparison of blood pressure, LVET and CO/SV measures with respective Gold Standards | Device: Non-invasive hemodynamic measurements<br>* Non-invasive hemodynamic measurements<br>|
| Group 2<br>Comparison of blood pressure and HRV measures with respective Gold Standards | Device: Non-invasive hemodynamic measurements<br>* Non-invasive hemodynamic measurements<br>|
| Group 3<br>Comparison of blood pressure and CO/SV measures with respective Gold Standards | Device: Non-invasive hemodynamic measurements<br>* Non-invasive hemodynamic measurements<br>|

What is the study measuring?
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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 |