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Clinical Trials/NCT03121144
NCT03121144
Completed
Not Applicable

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

Masimo Corporation1 site in 1 country34 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pressure Ulcer
Sponsor
Masimo Corporation
Enrollment
34
Locations
1
Primary Endpoint
Usability Validation of Masimo Centroid System
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
March 27, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age
  • ICU patient
  • Primarily bedbound subjects
  • Able to be monitored for a minimum of approximately 8 hours

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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