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临床试验/NCT00753129
NCT00753129已完成2 期

Influence of Head Elevation in Prone Position on Gas Exchange and Lung Mechanics in Patients With ALI/ARDS

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
1
主要终点
PaO2/FiO2 ratio

研究概览

简要总结

Semi-recumbent position leads to improvement of gas exchange and lung mechanics in patients suffering from ALI or ARDS. Prone positioning leads to similar effects. To date, no data on the combination of these two positioning measures exist. The investigators hypothesize that head elevation in prone position leads to improvement in gas exchange and lung mechanics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
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
否

入选标准

  • •Mechanically ventilated
  • •ALI or ARDS
  • •No contraindications for prone position

排除标准

  • •Patient < 18 or > 89 years old
  • •Pregnancy
  • •Elevated intracranial pressure
  • •PaO2/FiO2 - ratio < 60
  • •Open abdomen
  • •Instable spine
  • •Malignant arrhythmias
  • •Severe hemodynamic instability

研究组 & 干预措施

1

Active Comparator

Start with turning to prone position without head elevation, after 2 hours 30° head elevation, after 2 hours back to PP without head elevation.

干预措施: Prone position with head elevation (Procedure)

2

Active Comparator

Start with turning to prone position with 30° head elevation, after 2 hours PP without head elevation, after 2 hours back to 0° PP.

干预措施: Prone position with head elevation (Procedure)

结局指标

主要结局

PaO2/FiO2 ratio

时间窗: Study period (5 hours on 2 consecutive days)

次要结局

  • PaCO2, Compliance (Chest wall, lung, respiratory system)(Study period (5 hours on 2 consecutive days))

研究者

申办方类型
Other

研究点 (1)

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