NCT04685733

Caretaker Hemodynamic Parameters Validation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: CareTaker Medical LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Pressure
• Cardiac Output
• Left Ventricular Ejection Time
• Heart Rate Variability

Interventions

Type	Name	Description
DEVICE	Non-invasive hemodynamic measurements	Non-invasive hemodynamic measurements

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2020-12-28
• Last updated: 2020-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study