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.

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.

Study Overview

• Status: Unknown
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Freedom Bed; Other: Standard hospital bed

Detailed Description

This study will include 8 vent dependent subjects with comparable diagnoses and nutritional levels. Of the subjects selected, 4 subjects will be placed on Freedom Beds and 4 will be placed on standard hospital beds for a period not less than 6 months. A waiver of informed consent is required prior to bed placement and data collection. Consented subjects will have primary and secondary diagnosis recorded, pressure mapping in supine 30-degree elevation, assessment of ventilator / oxygen support measured, oxygenation levels, nutrition levels, and estimated cardiac condition. Subjects will receive daily skin assessments and treatment as prescribed by the attending physician with weekly measurements and reporting of values. Subjects will continue until they reach one of the study endpoints: 1) discharge from the vent unit, or 2) withdrawal of informed consent, or 3) completion of the 6-month study.

Subjects placed on the Freedom Bed will be automatically turned in accordance with positions determined as optimal by initial pressure mapping and approved by the attending physician. All programmable turning angles, dwell times, head and leg elevations must be "dialed in" within a week of the study beginning. Any modification to the program during the study must be approved by the care team and documented accordingly.

Subjects placed on standard hospital bed will require manual re-positioning every 2 hours. All turning and/or re-positioning must be timed and documented.

Subjects who experience either development of pressure injuries, or worsening of their skin condition to the point a specialty bed is required will be deemed a test failure.

The primary and secondary outcome measures documented on each subject throughout the week will be collected by the Clinical Research Coordinator (CRC) on a weekly basis and submitted to the Principal Investigator. The weekly reports will then be consolidated by the CRC into a monthly report and submitted to the Institutional Review Board (IRB), Principal Investigators (PI) and Supervising Authorities (SA) for review.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Freedom Bed; Freedom Bed Continuous Lateral Rotation Therapy System	Device: Freedom Bed; 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.
OTHER: Standard Hospital Bed & Protocol; Standard Hospital Bed with manual caregiver re-positioning every 2 hours	Other: Standard hospital bed; Caregiver turning patients to one side then the other every 2 hours for pressure relief over bony prominence's.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Pressure Injury	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Pneumonia	12 months

Collaborators and Investigators

• Sponsor: Northeast Center for Rehabilitation and Brain Injury
• Collaborators: Probed Medical USA
• Investigators: Study Director: Lorraine McCalister, M.S., Director Of Therapy, Northeast Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2017
• Study Completion (ANTICIPATED): November 1, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (ESTIMATE): February 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Wounds and Injuries; Skin Ulcer; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Brain Injuries, Traumatic; Spinal Cord Injuries; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: Protocol 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No