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临床试验/NCT02246946
NCT02246946已完成不适用

Efficacy of the Addition of Positive Airway Pressure to Conventional Chest Physiotherapy in the Time to Resolution of Pleural Effusion After Drainage

Universidade Cidade de Sao Paulo2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2014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
156
试验地点
2
主要终点
Duration of chest tube drainage

研究概览

简要总结

The purpose of this study is to determine if the addition of intermittent positive airway pressure breathing (specific lung expansion technique) to conventional chest physiotherapy chest drainage is effective to accelerate the reabsorption of pleural effusion and consequently decrease the duration of chest tube drainage and respiratory system impairment. These effects would decrease hospital stay lengths and the incidence of pulmonary complications.

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 (Outcomes Assessor)

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

  • age over 18 years
  • presence of pleural effusion
  • have undergone chest drain for fewer than 24 hours

排除标准

  • contraindication to the use of non-invasive equipment that generates positive airway pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion, hemodynamic instability requiring vasopressor therapy, systolic blood pressure < 90 mmHg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting, upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours, pneumothorax or bullous emphysema)

结局指标

主要结局

Duration of chest tube drainage

时间窗: All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage

The criteria for the removal the chest drain will an output of transudative fluid over 24h ≤ 200 ml and full lung expansion on chest radiography

次要结局

  • Length of hospital stay(All patients will be followed for the duration of hospital stay, an expected average of 10 days)
  • Spirometry(On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol)
  • Pulmonary complications(All patients will be followed for the duration of hospital stay, an expected average of 10 days)
  • Peripheral Oxygen Saturation(On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol)

研究者

发起方
Universidade Cidade de Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriana Claudia Lunardi

Professor on Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo

Universidade Cidade de Sao Paulo

研究点 (2)

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