Trial Outcomes & Findings for Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection (NCT NCT03121144)
NCT ID: NCT03121144
Last Updated: 2020-06-01
Results Overview
The number of participants enrolled to assess the usability of the Masimo Centroid System.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
At least 8 hours
Results posted on
2020-06-01
Participant Flow
Participant milestones
| Measure |
Masimo Centroid System
All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Baseline characteristics by cohort
| Measure |
Masimo Centroid System
n=34 Participants
All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Native Hawaiian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At least 8 hoursThe number of participants enrolled to assess the usability of the Masimo Centroid System.
Outcome measures
| Measure |
Masimo Centroid System
n=34 Participants
All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.
|
|---|---|
|
Usability Validation of Masimo Centroid System
|
34 Participants
|
Adverse Events
Masimo Centroid System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60