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临床试验/NCT01756742
NCT01756742已完成不适用

Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2009年2月1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
112
试验地点
1
主要终点
Assessment of the severity of respiratory disease

研究概览

简要总结

Pleural effusion and the complexity of diagnosis and treatment make planning and delivering care challenging. Respiratory physiotherapy is recommended, and should be applied during the first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a University Hospital.

详细描述

Approximately 1.5 million patients are diagnosed with pleural effusion each year in the United States . Pleural effusion (PE) is an accumulation of fluid in the pleural space that is classified as transudate or exudate according to its composition and underlying pathophysiology. The goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. While some authors (REF) propose respiratory physiotherapy, in the majority of the cases only the medical treatment combined with the pleural fluid removal by thoracentesis are the most common practice. The objective of this study is verify the effectiveness of respiratory physiotherapy in pleural effusion

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of pleural effusion based on the presence of a consistent radiological finding on simple posteroanterior and lateral chest X-rays, and decubitus lateral in cases of small PE.

排除标准

  • •Non diagnosis of pleural effusion

研究组 & 干预措施

Respiratory physiotherapy

Experimental

54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.

干预措施: Respiratory physiotherapy (Other)

Conservative treatment

Placebo Comparator

49 people were recruited in this group. These participants received conservative medical treatment intervention

干预措施: Conservative treatment (Other)

结局指标

主要结局

Assessment of the severity of respiratory disease

时间窗: baseline, 12 months

A spirometry is used to assess severity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second, and the forced expiratory flow over the middle one half of the forced vital capacity.

次要结局

  • Severity in the pleural effusion repercussion(baseline, 12 months.)
  • Length of the hospital stay(baseline, 12 months)

研究者

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

Marie Carmen Valenza

Assistant professor

Universidad de Granada

研究点 (1)

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