NCT04456179

Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure

Evaluation of Sensifree's PPG Based Continuous & Non-Invasive Blood Pressure Monitoring System in Comparison to Invasive Radial Arterial Line

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sensifree Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Blood Pressure Measurement

Interventions

Type	Name	Description
DEVICE	GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor	PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
DEVICE	Arrow® arterial catheterization kit (Teleflex)	Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform

Timeline

• Start date: 2020-02-03
• Primary completion: 2020-02-06
• Completion: 2020-02-06
• First posted: 2020-07-02
• Last updated: 2020-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study