NCT03121144CompletedNot Applicable
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Usability Validation of Masimo Centroid System
Study Overview
Brief Summary
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Masimo Centroid System
Experimental
Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
Intervention: Masimo Centroid System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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