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临床试验/NCT02125747
NCT02125747已完成不适用

Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Respiratory muscle strength

研究概览

简要总结

The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease.

详细描述

Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) is defined as an event in the natural course of the disease characterized by a change in the patient's usual symptoms (dyspnea, cough and/or sputum) that may not be explained by the daily variations and requires a change in regular medication.

Because AE-COPD result in impairment of both pulmonary and respiratory muscle functions, as well as an increasing impact on costs, priority should be given to interventions to slow the progression of the disease, prevention of exacerbations and reduce the risk of comorbidity.

Chest physiotherapy is often used in hospitalized patients with AE-COPD with the aim of favoring the removal of secretions and thus to improve the ventilation perfusion (V/Q), and therefore the function lung. The limited scientific evidence has determined that their use is controversial and not routinely recommended in clinical practice guidelines. Current clinical guidelines in the treatment of COPD are unable to rule on the application of respiratory therapy during exacerbations, since there is little scientific evidence of its benefits in the short and long term.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Hospitalized patients with acute exacerbation of COPD.
  • Inclusion Criteria:
  • age over 18 years,
  • hospitalized patients and
  • acute exacerbation of COPD.

排除标准

  • Previous history of any chronic respiratory disease and
  • not to have performed any kind of general or respiratory training in the previous 3 months.

结局指标

主要结局

Respiratory muscle strength

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 10 days

Respiratory muscle strength is assessed through maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) using a pressure transducer connected to a digital register system. The MIP is measured at mouth during a maximum effort from residual volume against occluded airway. To determine the MEP, patients performed a maximum expiratory effort from total lung capacity in the face of the occluded airway.

次要结局

  • Measure of safety and tolerability(Participants will be followed for the duration of hospital stay, an expected average of 10 days)
  • Adverse events as a measure of safety and tolerability(One year after hospital discharge)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esther Marco Navarro

PhD

Parc de Salut Mar

研究点 (2)

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