Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection

May 15, 2020 updated by: Masimo Corporation
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 18 years of age
  2. ICU patient
  3. Primarily bedbound subjects
  4. Able to be monitored for a minimum of approximately 8 hours

Exclusion Criteria:

  1. Pregnancy
  2. Prisoner status
  3. Pressure injury stage 2, 3, or ungroupable
  4. Has a pacemaker or internal defibrillator
  5. Has a history of complications with a similar study
  6. Has any medical condition which in the judgment of the Investigator, renders them inappropriate for participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Masimo Centroid System
Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
Device: Masimo Centroid System
Noninvasive positional monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability Validation of Masimo Centroid System
Time Frame: At least 8 hours
The number of participants enrolled to assess the usability of the Masimo Centroid System.
At least 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

March 27, 2019

Study Completion (ACTUAL)

March 27, 2019

Study Registration Dates

First Submitted

March 27, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (ACTUAL)

April 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAMS0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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