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OpenTrials
Completed

NCT Number: NCT03121144

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

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

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Key information

Conditions

Pressure Ulcer Falls Injury Pressure Injury Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Masimo Centroid System

Device

Noninvasive positional monitoring device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2017
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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