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Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies

NCT04100668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-09-24

No results posted yet for this study

Summary

The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter.

The study will be split into two phases: the first phase will collect data for morphology analysis and algorithm development, the second phase will compare device performance to the reference invasive blood pressures. A secondary objective is to evaluate signal morphology changes due to changes in subject arm position.

Conditions

  • Blood Pressure Measurement

Interventions

DEVICE

Sensifree's Alpha sensor

RF based, wrist mounted sensor, that acquires a high fidelity signal originating at the radial artery, and constructs a pressure waveform

DEVICE

Arrow® arterial catheterization kit (Teleflex)

Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform

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

Sponsors & Collaborators

  • Sensifree Ltd.

    lead INDUSTRY

Principal Investigators

  • Arthur Ruiz Cabrera, M.D

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2017-09-29
Completion
2017-09-29
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 NCT04100668 on ClinicalTrials.gov