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NCT03121144 Clinical Trial

Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection

Pressure Ulcer Clinical Trial

Official title:
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03121144
Other study ID # RAMS0006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date March 27, 2019

Study information
Verified date May 2020
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date March 27, 2019
Est. primary completion date March 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Masimo Centroid System
Noninvasive positional monitoring device

Locations
Country Name City State
United States Baylor University Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Usability Validation of Masimo Centroid System The number of participants enrolled to assess the usability of the Masimo Centroid System. At least 8 hours
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