Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The time taken to intubate a double-lumen tube
研究概览
简要总结
The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.
详细描述
Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen tube intubation because of its larger outer diameter and the more rigid feature. Moreover, the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the tube-related complications, we are trying to compare the individually angle-modified tube and the manufacturer-provided-angled tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing thoracic surgery under one lung ventilation
- •Subjects older than 20 yrs who can give written informed consent
排除标准
- •Those who need rapid sequence intubation
- •Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation)
- •Those with oropharyngeal obstructive disease (including tumor, foreign body)
- •Those who are expected prolonged intubation after surgery
- •Those who are pregnant
研究组 & 干预措施
Control group
Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien)
干预措施: Mallinckrodt endobronchial tube with a conventional angle (Device)
Tube angle modification
The angle of the double lumen tube(MallinckrodeTM endotracheal tube) is modified individually.At sniffing position, the distal tip of the tube is placed at the patient's cricoid cartilage level and the tube is bent at the intersection point of the two airway axes (oropharyngeal axis and tracheal axis) with an angle between the two axes.
干预措施: Mallinckrodt endotracheal tube with a modified angle (Device)
结局指标
主要结局
The time taken to intubate a double-lumen tube
时间窗: within 60 sec
The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords
次要结局
- The number of attempts needed for successful intubation(Intubation)
- Postoperative sore throat, hoarseness or dysphagia(30 minutes and 24hours after extubation)
- The time taken for the first attempt of intubation(within 60 sec)
研究者
Jong Hwan Lee
Assistant Professor
Samsung Medical Center