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

NCT03121144 | Completed Results FDA Device

• 1 other identifier: RAMS0006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pressure Ulcer; Pressure Injury; Falls Injury

Outcome Measures

Primary Outcomes (1)

• Usability Validation of Masimo Centroid System

  The number of participants enrolled to assess the usability of the Masimo Centroid System.

  At least 8 hours

Study Arms (1)

Masimo Centroid System

EXPERIMENTAL

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

Device: Masimo Centroid System

Interventions

Masimo Centroid System DEVICE

Noninvasive positional monitoring device

Masimo Centroid System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• ICU patient
• Primarily bedbound subjects
• Able to be monitored for a minimum of approximately 8 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vikram Ramakanth
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

(949) 297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 19, 2017
• Study Start: March 1, 2017
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: June 1, 2020
• Results First Posted: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)