跳至主要内容
临床试验/NCT00475579
NCT00475579已完成4 期

Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia

Hospital Universitario de Canarias0 个研究点目标入组 280 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
280
主要终点
Ventilator-associated pneumonia

研究概览

简要总结

Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube

详细描述

Subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing VAP. Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients expected to require mechanical ventilation for more than 24 hours

排除标准

  • Age <18 years,
  • Pregnancy,
  • Blood leukocytes counts <1000 cells/mm3,
  • Solid or haematological tumour,
  • Immunosuppressive therapy

结局指标

主要结局

Ventilator-associated pneumonia

时间窗: 8 months

次要结局

  • Late-onset ventilator-associated pneumonia(8 months)

研究者

申办方类型
Other

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