Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- procedure failure of ultrasound to provide this anatomical information and ease of perform
研究概览
简要总结
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
详细描述
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
Patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All intubated and mechanically ventilated patients indicated for a tracheostomy
排除标准
- •Patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.
结局指标
主要结局
procedure failure of ultrasound to provide this anatomical information and ease of perform
时间窗: During percutaneous tracheostomy an expected average time 20 minutes
occurence of a major complications: bleeding, subcutaneous emphysema, oesophageal perforation, number of applied needle interventions, procedure duration, cardiorespiratory arrest
次要结局
- Pneumothorax(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Accidental decannulation(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Minor bleeding(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- procedure time(during percutaneous tracheostomy ( average expected time 20 minutes))
- Tracheal posterior wall injury(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Major bleeding(During the procedure an expected average of 20 minutes)
- Cardiorespiratory arrest(during percutaneous tracheostomy an expected average of 20 minutes)
研究者
Aykut Saritas
principal investigator
Tepecik Training and Research Hospital