Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- railroading grade
研究概览
简要总结
One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB easier than the Shilly tube.
In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2
排除标准
- •abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI > 35
结局指标
主要结局
railroading grade
时间窗: an average of 2 minutes
grade of ease of railroading over fibreoptic bronchoscope. 1. no difficulty passing the tube 2. obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2) 3. obstruction necessitating more than one manipulation or external laryngeal manipulation 4. direct laryngoscope was required
次要结局
- insertion time(an average of 2 minutes)
- number of patients with complication of hoarseness, sore throat, and swallowing difficulty(an average of 30 minutes)
- number of patients with trauma around glottis, observed by FOB(an average of 2minutes)
- number of patients with tube repositioning during the surgery(an average of 3.5 hours)
研究者
DAE HEE KIM
Associate professor
Ajou University School of Medicine