Back to resultsUsability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Primary Purpose
Pressure Ulcer, Pressure Injury, Falls Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Masimo Centroid System
Sponsored by
About this trial
This is an interventional other trial for Pressure Ulcer
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:
- 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
Sites / Locations
- Baylor University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Masimo Centroid System
Arm Description
Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
Outcomes
Primary Outcome Measures
Usability Validation of Masimo Centroid System
The number of participants enrolled to assess the usability of the Masimo Centroid System.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03121144
Brief Title
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Official Title
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Pressure Injury, Falls Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masimo Centroid System
Arm Type
Experimental
Arm Description
Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
Intervention Type
Device
Intervention Name(s)
Masimo Centroid System
Intervention Description
Noninvasive positional monitoring device
Primary Outcome Measure Information:
Title
Usability Validation of Masimo Centroid System
Description
The number of participants enrolled to assess the usability of the Masimo Centroid System.
Time Frame
At least 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
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