Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
NCT ID: NCT03121144
Last Updated: 2020-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2017-03-01
2019-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Masimo Centroid System
Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
Masimo Centroid System
Noninvasive positional monitoring device
Interventions
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Masimo Centroid System
Noninvasive positional monitoring device
Eligibility Criteria
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Inclusion Criteria
2. ICU patient
3. Primarily bedbound subjects
4. Able to be monitored for a minimum of approximately 8 hours
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Baylor University Medical Center
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RAMS0006
Identifier Type: -
Identifier Source: org_study_id
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