Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Virginia | OTHER |
| Yale University | OTHER |
| Orange County Research Center | OTHER |
Not provided
Not provided
Not provided
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Comparison of blood pressure, LVET and CO/SV measures with respective Gold Standards |
| |
| Group 2 | Comparison of blood pressure and HRV measures with respective Gold Standards |
| |
| Group 3 | Comparison of blood pressure and CO/SV measures with respective Gold Standards |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive hemodynamic measurements | Device | Non-invasive hemodynamic measurements |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Unable to give written assent
Not provided
Not provided
Not provided
Subjects will be patients, > 18 years of age, who are able and willing to participate and have given written assent
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Baruch, PhD | Caretaker Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caretaker Medical | Charlottesville | Virginia | 22901 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided