The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea
研究概览
简要总结
The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.
详细描述
How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with American Society of Anesthesiologists physical status I-III
- •More than 18 years of age
- •Requiring DLT for thoracic surgery
排除标准
- •risk of regurgitation and pulmonary aspiration
- •history of gastroesophageal reflux, pregnancy
- •scheduled tracheostomy and postoperative prolonged ventilation in ICU
- •patients with limited neck extension (< 35°)
- •a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
- •a sternomental distance of less than 12.5 cm with the head fully extended
- •mouth can not open
研究组 & 干预措施
Tranditional fiberoptic bronchoscopy
The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by traditional fiberoptic bronchoscopy.
干预措施: Tranditional fiberoptic bronchoscopy (Device)
Modified fiberoptic bronchoscopy
The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by modified fiberoptic bronchoscopy.
干预措施: Modified fiberoptic bronchoscopy (Device)
Flexible Trachway intubating stylet
We used Flexible Trachway intubating stylet to facilitate the accurate placement of left-sided double lumen endobronchial tube into the left main bronchus.
干预措施: Flexible Trachway intubating stylet (Device)
结局指标
主要结局
Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea
时间窗: 12 month
次要结局
- The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea(12 month)
- The outcome measure is mean blood pressure (MAP) during intubation period(12 month)
- The outcome measure is the heart rate (HR) during intubation period(12 month)
- The outcome measure is the incidence of hypoxemia(12 month)
- The outcome measure is the incidence of hoarseness(12 month)
- The outcome measure is the incidence of sore throat(12 month)