Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-27 @ 4:42 PM
Study NCT ID:
NCT03048357
Status:
UNKNOWN
Last Update Posted:
2017-04-17
First Post:
2017-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Northeast Center for Rehabilitation and Brain Injury
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: