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临床试验/NCT06025370
NCT06025370已完成不适用

Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Skin/Bed pressures

研究概览

简要总结

Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS). Despite the benefits of PP, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours.

There are 2 PP techniques:

  1. Positioning with arms alongside the body
  2. Swimmer's position At present, no study compares or has compared prospectively, the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores, nor on secondary effects in intensive care.

Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces. The investigators have acquired a pressure-measuring device, a mattress topper which is attached to the resuscitation mattress and which, connected to a PC, provides a live display of the pressures between the patient and the mattress.

The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers, which would enable them to obtain the world's first data on the real pressures generated during PP.

研究设计

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

入排标准

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

入选标准

  • Male or female
  • Major volunteer

排除标准

  • Volunteers with cervical mobility problems preventing them from rotating their head 90°
  • Volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction.
  • Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test).
  • Volunteer not affiliated to a French social security system
  • Volunteer protected by law

结局指标

主要结局

Skin/Bed pressures

时间窗: 5 minutes

Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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