Gao Youguang, Lin Bo, Huang Jinghao, Lin Xianzhong, Lin Caizhu
Department of Anesthesiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian Province, People's Republic of China.
Trials. 2019 Mar 15;20(1):166. doi: 10.1186/s13063-019-3263-1.
Tracheal intubation with the patient in the lateral position is difficult because the laryngeal view is compromised during direct laryngoscopy. Flexible video endoscopes may facilitate intubation even when laryngeal views are poor on direct laryngoscopy because the patients are positioned laterally. Thus, this trial aims to compare the efficacy of flexible video endoscopes to Macintosh laryngoscopes for orotracheal intubation in the lateral position and to investigate their feasibility, i.e., whether the use of the two devices in combination can secure the airway when endotracheal intubation in the lateral position has failed using one device.
This will be a prospective, randomized, single-center, clinical trial. One hundred and seventy-four patients aged 18-65 years, who have been scheduled to undergo tracheal intubation under uniform general anesthetic techniques for elective kidney surgery in the lateral decubitus position will be randomly divided into the flexible video endoscope and the Macintosh laryngoscope groups. Primary outcomes include intubation time and intubation success rate. Secondary outcomes include overall user satisfaction (graded from 1 to 10 (1 = very poor, 10 = excellent)) and perioperative side effects and complications, such as frequency of esophageal intubation, lip or dental injury, sore throat, and hoarseness.
The trial will clarify the efficacy of intubation with a Macintosh laryngoscope and a flexible video endoscope in the lateral position, and whether the two devices could be used in combination to secure the airway in cases where endotracheal intubation in the lateral position has failed with one device.
Chinese Clinical Trial Register, ChiCTR- IOR-15007175 . Registered on 6 October 2015.
患者处于侧卧位时进行气管插管较为困难,因为直接喉镜检查时视野受限。即使在直接喉镜检查时视野不佳,由于患者处于侧卧位,可弯曲视频喉镜仍可能有助于插管。因此,本试验旨在比较可弯曲视频喉镜与麦氏喉镜用于侧卧位经口气管插管的效果,并研究其可行性,即当侧卧位气管插管使用一种设备失败时,两种设备联合使用能否确保气道安全。
这将是一项前瞻性、随机、单中心临床试验。174例年龄在18至65岁之间、计划在全身麻醉技术统一的情况下在侧卧位进行择期肾脏手术时接受气管插管的患者将被随机分为可弯曲视频喉镜组和麦氏喉镜组。主要结局包括插管时间和插管成功率。次要结局包括总体用户满意度(从1至10分进行评分(1=非常差,10=优秀))以及围手术期的副作用和并发症,如食管插管的频率、唇部或牙齿损伤、咽痛和声音嘶哑。
该试验将阐明麦氏喉镜和可弯曲视频喉镜在侧卧位插管的效果,以及在侧卧位气管插管使用一种设备失败的情况下,两种设备联合使用能否确保气道安全。
中国临床试验注册中心,ChiCTR-IOR-15007175。于2015年10月6日注册。