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临床试验/NCT02832609
NCT02832609已完成不适用

Mechanisms of Orthopnea in Stable Obese Patients

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年3月最近更新:
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
30
试验地点
2
主要终点
closing volume by nitrogen washout method

研究概览

简要总结

The purpose of this study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing volume to change in dyspnea with position would be dependent on expiratory flow limitation in the sitting position.

In stable obese subjects, in sitting and supine positions, the investigators measured Borg dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen expiration test, from which the investigators determined closing volume and closing capacity, slope of phase III, and opening capacity.

Orthopnea was defined as any increase in the Borg score in the supine position from its value in the sitting position

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • obese (BMI ≥ 30)
  • stable condition
  • 20 < Age < 60 years

排除标准

  • other respiratory disorder (COPD)
  • left cardiac insufficiency

研究组 & 干预措施

sitting position

No Intervention

measurement in the sitting position

supine position

Active Comparator

measurement in the sitting position

干预措施: Supine (Other)

结局指标

主要结局

closing volume by nitrogen washout method

时间窗: 30 minutes after changing position (hour 2)

次要结局

  • static lung volumes by plethysmography(30 minutes after changing position (hour 2))
  • expiratory flow limitation by NEP test(30 minutes after changing position (hour 2))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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