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

NCT04456179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-07-02

No results posted yet for this study

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.

Conditions

  • Blood Pressure Measurement

Interventions

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

Sponsors & Collaborators

  • Sensifree Ltd.

    lead INDUSTRY

Principal Investigators

  • Arthur Ruiz Cabrera, M.D

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2020-02-06
Completion
2020-02-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456179 on ClinicalTrials.gov