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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

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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: Freedom Bed Other: Standard hospital bed Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2017
Estimated Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Incidence of Pressure Injury [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Incidence of Pneumonia [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048357


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

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Responsible Party: Annmarie Belfiglio, Occupational Therapy Coordinator, Northeast Center for Rehabilitation and Brain Injury
ClinicalTrials.gov Identifier: NCT03048357     History of Changes
Other Study ID Numbers: Protocol 2
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Pressure Ulcer
Crush Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Skin Ulcer
Skin Diseases