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

Not Applicable

Completed

• Conditions: Pressure Ulcer; Pressure Injury; Falls Injury

• Registration Number: NCT03121144
• Lead Sponsor: Masimo Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-19
• Primary Completion: 2019-03-27
• Study Completion: 2019-03-27
• Status Verified: 2020-05
• Results First Submitted: 2020-05-15
• Results First Submitted QC: 2020-05-15
• Last Update Submitted: 2020-05-15
• Results First Posted: 2020-06-01
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Usability Validation of Masimo Centroid System	At least 8 hours	The number of participants enrolled to assess the usability of the Masimo Centroid System.

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States