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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
6
PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
Clinimark Lab
Louisville, Colorado, United States
Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans
Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg): 1. Hand grip 2. Weight lifting 3. Leg static effort
Time frame: 3-4 hours per subject
Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device
Comparison of BP values (Systolic, Diastolic, MAP) that are calculated by the investigational device to the BP values measured by the arterial line during isometric effort comprising a combination of the following isometric efforts on a subject's blood pressure: 1. Hand grip 2. Weight lifting 3. Leg static effort
Time frame: 3-4 hours per subject
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.