跳至主要内容
临床试验/NCT01792258
NCT01792258Unknown不适用

Procedures, Complications and Follow-up of Percutaneous Tracheostomies in Intensive Care Unit

University of Genova1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Safety of percutaneous tracheostomy

研究概览

简要总结

Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper airway obstruction. Many studies have focused on the comparison between different PDT techniques and complication. The aim of our study is to evaluate the procedural features, complications, ICU mortality, quality of life, post-discharge mortality of patients undergoing different PDT techniques performed in ICU.

研究设计

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

入排标准

年龄范围
18 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • indication for tracheostomy

排除标准

  • infectious disease of neck

结局指标

主要结局

Safety of percutaneous tracheostomy

时间窗: at the beginning and at the end of the procedure

次要结局

  • Quality of life(at 3, 6 and 12 months after tracheostomy)
  • Early complications(in the first 24 hours from the end of the procedure)
  • Mortality(at 3, 6 and 12 months from tracheostomy)
  • Late complications(from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks))
  • Evaluation of organ function(At 3, 6 , and 12 months after tracheostomy)
  • Quality of voice(At 3,6, 12 months after tracheostomy)

研究者

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

Paolo Pelosi

Professor

University of Genova

研究点 (1)

Loading locations...

相似试验