NCT01899352Unknown不适用
Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units - a Prospective Study by Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Mortality at ICU discharge
研究概览
简要总结
Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •indications for tracheostomy
排除标准
- •Infection/inflammation of neck tissue
- •Previous neck surgery causing abnormal anatomy of the site
- •Recent surgery of cervical spine
研究组 & 干预措施
Tracheostomy
Other
The investigators will enroll all the critical ill patients undergoing tracheostomy performed in intensive care units
干预措施: Tracheostomy (Procedure)
结局指标
主要结局
Mortality at ICU discharge
时间窗: within 2 days after discharge
次要结局
- Quality of Life(within 2 days after discharge, at 3, 6 and 12 months after tracheostomy)
- Laryngeal organ function(within 2 days after discharge, at 3, 6 and 12 months after tracheostomy)
- Late complications(from day 2 until the discharge)
- Procedural findings of percutaneous tracheostomy(at the beginning and at the end of tracheostomy procedures)
- Early complication(in the first 24 hours from the end of the procedure)
研究者
Paolo Pelosi
Professor-head of intensive care unit
University of Genova
研究点 (10)
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