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临床试验/NCT00817947
NCT00817947已完成3 期

An Assessment of the Short-Term Effects of the Airway Clearance Technique of High Frequency Chest Wall Oscillation in People With Cystic Fibrosis

Royal Brompton & Harefield NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Weight of sputum expectorated

研究概览

简要总结

High frequency chest wall oscillation (HFCWO) has been shown to increase tracheal mucous clearance compared with control. These observations led to the development of 'The Vest' which is a non-stretchable jacket connected to an air-pulse generator and worn by the patient over the chest wall. The generator rapidly inflates and deflates 'The Vest' which gently compresses and releases the chest wall between 5 and 20 times per second. This generates mini-coughs which are said to dislodge mucus from the bronchial walls and to facilitate its movement up the airways. In addition 'The Vest' has been shown to reduce the viscosity of mucus and this should further enhance mucous clearance. The technique has, for many years, been widely used in the United States of America as an alternative to the European airway clearance regimens of the active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure, but 'The Vest' has only recently been registered for use in Europe. It is important that the airway clearance regimen of 'The Vest' be compared with the alternative airway clearance regimens widely used in Europe.

Hypothesis: In people with cystic fibrosis 'The Vest' will lead to the expectoration of an increased weight of sputum during treatment sessions compared with alternative airway clearance regimens.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • diagnosis of cystic fibrosis
  • 16 years of age or over
  • forced expiratory volume in one second greater than or equal to 25 percent of predicted
  • hospitalised patients in a stable clinical state

排除标准

  • current severe haemoptysis
  • rib fractures
  • pregnancy
  • inability to give consent

结局指标

主要结局

Weight of sputum expectorated

时间窗: Twenty-four hours

次要结局

  • Forced expiratory volume in one second(One hour (before and 30 minutes after treatment))

研究者

研究点 (2)

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