Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in gas-exchange
研究概览
简要总结
Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. This situation may lead to many disadvantages for ventilation and airway protection of critically ill patients during the procedures. The use of double lumen endotracheal tube dedicated to the percutaneous tracheostomies may:
- improve the ventilation of patients during the procedure,
- protect the posterior tracheal wall from damage related to the different step of tracheostomies,
- protect the lungs from blood and secretions coming down from the chosen site of tracheostomy.
So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen endotracheal tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- 否
入选标准
- •age ≥ 18 years and at least one of following criteria:
- •prolonged endotracheal intubation
- •prolonged mechanical ventilation
- •difficult/prolonged weaning
- •inability to protect the airway
排除标准
- •infection of neck tissues
- •previous surgical neck interventions
- •recent surgical interventions or fracture of the cervical spine
研究组 & 干预措施
Double lumen endotracheal tube tracheostomy
Tracheostomy with a dedicated double lumen endotracheal tube
干预措施: Double lumen endotracheal tube tracheostomy (Device)
结局指标
主要结局
change in gas-exchange
时间窗: at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)
The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio
次要结局
- late complications(from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks))
- early complications(in the first 24 hours from the end of the procedure)
- change in air-trapping(at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes))
- change in peak airway pressure(at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes))
- change in plateau airway pressure(at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes))
- change in arterial carbon dioxide(at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes))
研究者
Paolo Pelosi
Full Professor chair of Anesthesiology and Intensive Care Medicine. Chief of Intensive Care Unit
University of Genova