N/A
Completed N=34
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Pressure Ulcer · Pressure injury · Falls Injury
Source: ClinicalTrials.gov NCT03121144 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Usability Validation of Masimo Centroid System — 34 Participants
Summary
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability Validation of Masimo Centroid System |
34 | — |
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. Informational only — not medical advice.