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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.

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ClinicalTrials.gov Identifier: NCT03048357
Recruitment Status : Unknown
Verified April 2017 by Annmarie Belfiglio, Northeast Center for Rehabilitation and Brain Injury.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
Probed Medical USA
Information provided by (Responsible Party):
Annmarie Belfiglio, Northeast Center for Rehabilitation and Brain Injury

Tracking Information
First Submitted Date  ICMJE February 7, 2017
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date April 17, 2017
Actual Study Start Date  ICMJE September 1, 2016
Estimated Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Incidence of Pressure Injury [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03048357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Incidence of Pneumonia [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pressure Ulcer
Intervention  ICMJE
  • 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
    Caregiver turning patients to one side then the other every 2 hours for pressure relief over bony prominence's.
Study Arms  ICMJE
  • Active Comparator: Freedom Bed
    Freedom Bed Continuous Lateral Rotation Therapy System
    Intervention: Device: Freedom Bed
  • Standard Hospital Bed & Protocol
    Standard Hospital Bed with manual caregiver re-positioning every 2 hours
    Intervention: Other: Standard hospital bed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2017
Estimated Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03048357
Other Study ID Numbers  ICMJE Protocol 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Annmarie Belfiglio, Northeast Center for Rehabilitation and Brain Injury
Study Sponsor  ICMJE Northeast Center for Rehabilitation and Brain Injury
Collaborators  ICMJE Probed Medical USA
Investigators  ICMJE
Study Director: Lorraine McCalister, M.S. Director Of Therapy, Northeast Center
PRS Account Northeast Center for Rehabilitation and Brain Injury
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP