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临床试验/NCT03118960
NCT03118960Unknown不适用

Effectiveness of the Freedom Bed and Alternating Pressure Mattress in Treatment of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and /or Spinal Cord Injury

Northeast Center for Rehabilitation and Brain Injury1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
9
试验地点
1
主要终点
Incidence of Pressure Ulcers

研究概览

简要总结

This non-randomized clinical study will compare pressure injuries and the change in pressure injuries for subjects who are placed on the Freedom Bed compared to those placed on a standard Group II Low Air Loss/Alternating Pressure Mattress in the Ventilator Unit at Northeast Center for Rehabilitation and Brain Injury. Additionally, the incidence of pneumonia, urinary tract infections, circulatory performance, sleep deprivation and caregiver self-perception on performance will be monitored and documented.

详细描述

Detailed Description: This study will include 9 ventilator or oxygen dependent subjects with comparable diagnoses, nutritional levels and Stage III and/or IV pressure injuries. Of the subjects selected, 5 subjects will be placed on Freedom Beds and 4 will be placed on Group II Low Air Loss/Alternating Pressure Mattresses 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 injuries photographed and classified, assessment of ventilator/oxygen support measured, oxygenation levels, nutrition levels, and estimated cardiac condition. Subjects will receive daily treatment and wound care 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 ventilator unit, or 2) withdrawal of informed consent, or 3) completion of the 6-month study.

Subjects placed on Freedom Beds will be automatically turned in accordance with positions determined optimal 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 Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours. All turning and/or repositioning must be timed and documented.

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects or their legal representative able to provide written consent for study.
  • •subjects must be within the height and weight limits of the beds(height range 4'2"-6' 6" , weight range 50-300 lbs.)
  • •subjects must have an existing treatable stage 2 or Stage 3 wound.

排除标准

  • •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 obese.

研究组 & 干预措施

Freedom Bed

Active Comparator

Bed turns and positions subjects automatically for the healing and prevention of pressure injury

干预措施: Freedom Bed (Device)

Group II Low Air Loss/Alternating Pressure Mattress

Active Comparator

Bed provides subjects with alternating pressure with low air loss mattress for the healing and prevention of pressure injury

干预措施: Group II Low Air Loss/Alternating Pressure Mattress (Device)

结局指标

主要结局

Incidence of Pressure Ulcers

时间窗: 12 Months

Comparison between groups - Using scale for Healing (PUSH) Tool, Standardized Assessment of Pressure Injury

次要结局

  • Incidence of pneumonia in each group(12 months)

研究者

发起方
Northeast Center for Rehabilitation and Brain Injury
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annmarie Belfiglio

Occupational Therapy Coordinator

Northeast Center for Rehabilitation and Brain Injury

研究点 (1)

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