跳至主要内容
临床试验/NCT01285739
NCT01285739Unknown不适用

Eight-year Follow up in Tracheostomized COPD Patients Undergoing Domiciliary Non Invasive Mechanical Ventilation.

Fondazione Salvatore Maugeri1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
247
试验地点
1
主要终点
ventilator associated pneumonia (VAP)

研究概览

简要总结

The purpose of this study was to determine occurrence of ventilator associated pneumonia (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive mechanical ventilation (NIMV).

详细描述

Acute respiratory failure due to COPD is often treated with invasive mechanical ventilation through endotracheal intubation, followed by placement of a endotracheal canula. However, invasive ventilation is at risk of infective complications and is difficult to manage at home. In particular, invasive mechanical ventilation may be associated with ventilator associated pneumonia (VAP). VAP is usually suspected when the individual develops a new or progressive infiltrate on chest radiograph, leukocytosis, and purulent tracheobronchial secretions. When possible, we tried to put these tracheotomized patients in non invasive mechanical ventilation (NIMV)to avoid VAP. This population was followed for eight consecutive years and compared with patients in invasive home mechanical ventilation (IMV).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of COPD
  • Tracheostomy
  • Need of domiciliary invasive / non invasive ventilation

排除标准

  • Patients with COPD weaned from invasive / non invasive mechanical ventilation
  • Lack of tracheostomy

结局指标

主要结局

ventilator associated pneumonia (VAP)

时间窗: six months

VAP is usually suspected when the individual develops a new or progressive infiltrate on chest radiograph, leukocytosis, and purulent tracheobronchial secretions. Therefore white cell blood (WBC)count, procalcitonine (PCT), C-reactive protein (CRP) and tracheobronchial aspirate (TBA) were collected every 6 months. Chest X ray was performed only when a clinical suspect of VAP was advanced.

次要结局

  • Care givers involvement(Six months)
  • Blood gas analysis(Six months)

研究者

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

Ercole Zanotti

MD

Fondazione Salvatore Maugeri

研究点 (1)

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