Falls Injury, Pressure Injury, Pressure Ulcer
Conditions
Brief summary
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
Interventions
DEVICEMasimo Centroid System
Noninvasive positional monitoring device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age 2. ICU patient 3. Primarily bedbound subjects 4. Able to be monitored for a minimum of approximately 8 hours
Exclusion criteria
1. Pregnancy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability Validation of Masimo Centroid System | At least 8 hours | The number of participants enrolled to assess the usability of the Masimo Centroid System. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Masimo Centroid System All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Masimo Centroid System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Race/Ethnicity, Customized African American | 14 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Asian/Native Hawaiian | 1 Participants |
| Race/Ethnicity, Customized White | 17 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Usability Validation of Masimo Centroid System
The number of participants enrolled to assess the usability of the Masimo Centroid System.
Time frame: At least 8 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Masimo Centroid System | Usability Validation of Masimo Centroid System | 34 Participants |