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

Masimo

Status: Completed

Conditions: Pressure Ulcer; Pressure Injury; Falls Injury

Treatments: Device: Masimo Centroid System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03121144

RAMS0006

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Masimo Centroid System

Experimental group

Description:

Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered.

Treatment:

Device: Masimo Centroid System