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临床试验/NCT06661954
NCT06661954已完成不适用

Sacral Interface Pressure Mapping of Hospital Bed Systems

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Peak Sacral Pressure

研究概览

简要总结

The purpose of the research study is to investigate the peak sacral interface pressures of two separate hospital bed systems in the supine and 30 degrees head-of-bed elevation position.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •non-disabled
  • •can walk & stand independently
  • •can visit UAB SIM Lab once for 45 to 60 minutes

排除标准

  • •skin breakdown or compromising skin conditions

研究组 & 干预措施

Healthy Adult Volunteers

Experimental

One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant.

干预措施: Bed B - Head of Bed 0 degrees (Device)

Healthy Adult Volunteers

Experimental

One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant.

干预措施: Bed A - Head of bed at 30 degrees (Device)

Healthy Adult Volunteers

Experimental

One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant.

干预措施: Bed A - Head of Bed 0 degrees (Device)

Healthy Adult Volunteers

Experimental

One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant.

干预措施: Bed B - head of bed at 30 degrees (Device)

结局指标

主要结局

Peak Sacral Pressure

时间窗: minutes 1-3 and minutes 6-8

Peak sacral pressure is defined as the highest pressure within a 9-10 cm squared area under the coccyx. The area under coccyx was identified prior to each condition tested using the pressure mapping system. Presure was recorded continuously for 15 minutes. Because the mattresses tested were advertised as 'cycling' pressure, with the cycles set to 5 minutes, the average of minutes 1-3 and 6-8 were used for analysis. These periods represent different phases of the 'cycling' where sacral pressure would conceivably differ.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel Cowan

Associate Professor

University of Alabama at Birmingham

研究点 (1)

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