Blood Pressure Measurement Clinical Trial
Official title:
Evaluation of Sensifree's PPG Based Continuous & Non-Invasive Blood Pressure Monitoring System in Comparison to Invasive Radial Arterial Line
The purpose of this study is to evaluate methods to modify blood pressure in humans and measure the effectiveness of such methods. A secondary outcome is to evaluate the performance of an investigational continuous non-invasive blood pressure (cNIBP) device created by Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled conditions that include resting blood pressure and non-pharmacologically induced blood pressure changes.
On a first visit a screening procedure to verify inclusion / exclusion criteria are met will
be conducted. On the primary procedure visit, data collection will begin with the subjects
having the investigational device, ECG sensors, and 1 or more pulse oximetry sensors placed
on them for data collection and to monitor their safety for the duration of the study. A
physician will place an arterial line in the radial artery. The Sensifree cNIBP system will
be calibrated with an oscillometric and/or auscultatory blood pressure cuff measurement taken
on the arm opposite the arterial line.
A series of blood pressure changes will be induced, including various combinations of
methods.
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