N/A
N=34
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Pressure Ulcer · Pressure Injury · Falls Injury
Bottom Line
View on ClinicalTrials.gov: NCT03121144 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Usability Validation of Masimo Centroid System — 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Masimo Centroid System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability Validation of Masimo Centroid System |
34 | — |
Summary
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
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
Data sourced from ClinicalTrials.gov (NCT03121144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.