Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
Effectiveness of the Freedom Bed, Automatic Continuous Lateral Rotation Therapy System as Compared to a Standard Hospital Mattress With Manual Caregiver Turning Every 2 Hours for Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
1 other identifier
interventional
8
0 countries
N/A
Brief Summary
Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours on a standard Hospital Bed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedApril 17, 2017
April 1, 2017
1 year
February 7, 2017
April 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Pressure Injury
12 months
Secondary Outcomes (1)
Incidence of Pneumonia
12 months
Study Arms (2)
Freedom Bed
ACTIVE COMPARATORFreedom Bed Continuous Lateral Rotation Therapy System
Standard Hospital Bed & Protocol
OTHERStandard Hospital Bed with manual caregiver re-positioning every 2 hours
Interventions
Fully Integrated Lateral Rotation Bed System that automatically turns the patient to a specific angle in degrees between from 15-25 with dwell times between 1-120 minutes.
Caregiver turning patients to one side then the other every 2 hours for pressure relief over bony prominence's.
Eligibility Criteria
You may qualify if:
- Subjects or their legal representative able to provide written consent for study Must be rated between 6-12 on the Baden Scale Must be immobile and unable to preposition themselves. Must be within weight range of designated support surface.
You may not qualify if:
- Subjects with unstable spinal fractures. Subjects with significant involuntary spasms. Subjects with severe scoliosis. A user must be able to lie in a partial back lying position.
- Subjects considered morbidly obese.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lorraine McCalister, M.S.
Director Of Therapy, Northeast Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Occupational Therapy Coordinator
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 9, 2017
Study Start
September 1, 2016
Primary Completion
September 1, 2017
Study Completion
November 1, 2017
Last Updated
April 17, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share