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

Not Applicable

Completed

• Conditions: Pressure Ulcer; Pressure Injury; Falls Injury
• Interventions: Device: Masimo Centroid System

• 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

Arm && Interventions

Group	Intervention	Description
Masimo Centroid System	Masimo Centroid System	Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.

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