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Clinical Trial Summary

The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM") provides heart rate, continuous noninvasive blood pressure (BP), respiratory rate, stroke volume and cardiac output.


Clinical Trial Description

The device is currently undergoing IEC 60601 Medical Safety Standards testing and has already passed all FDA-required emission and discharge testing. The Vitalstream tracks central aortic BP via pulse analysis, specifically Pulse Decomposition Analysis ("PDA"), of the peripheral pulse at a distal site, typically finger. The device uses a low pressure [30-40 mmHg], pump-inflated, finger cuff that pneumatically couples arterial pulsations via a pressure line to a custom-designed piezo-electric pressure sensor for detection and analysis. Physiological data are communicated wirelessly to a tablet-based user interface via Bluetooth. The Vitalstream monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05905536
Study type Interventional
Source Wake Forest University Health Sciences
Contact Ashish Khanna, MD
Phone 513-658-5866
Email akhanna@wakehealth.edu
Status Recruiting
Phase N/A
Start date August 15, 2023
Completion date August 2024

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