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

Completed · Not applicable

Conditions studied: Pressure Ulcer, Pressure Injury, Falls Injury

In brief

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

Key facts

Study ID

NCT03121144

Run by

Masimo Corporation

People needed

34

Starts

2017-03-01

Expected to finish

2019-03-27

Last updated by the study team

2020-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Pregnancy
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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