Blood Pressure, Cardiac Output, Heart Rate Variability, Left Ventricular Ejection Time
Conditions
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.
Interventions
Non-invasive hemodynamic measurements
Sponsors
University of Virginia
Yale University
Orange County Research Center
CareTaker Medical LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cardiac output performance comparison | Paired measurements over approximately 1 hour time frame | Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min. |
| 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. |
| 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 |
Countries
United States
Outcome results
None listed