Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- The success rate of intubation
研究概览
简要总结
Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through camera, however, it requires cervical movement. Therefore, investigator hypothesized that the combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of intubation compared to the use of lightwand alone in cervical immobilized patients.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 20- 80 yrs
- •Patients scheduled surgery under the general anesthesia
排除标准
- •Patient who has history of gastro-esophageal reflux disease, previous airway surgery, anatomical abnormality in the upper airway, or coagulopathy
- •Patients with body mass index >35kg/m2, hemodynamic instability or loosening teeth
- •Patient who disagrees to participate this study or lacks decision-making ability, illiteracy, or foreigner
- •American Society of Anesthesiologists physical status ≥ 3
研究组 & 干预措施
video-laryngoscope guided lightwand
干预措施: Video-laryngoscope guided lightwand (Device)
lightwand
干预措施: lightwand alone (Device)
结局指标
主要结局
The success rate of intubation
时间窗: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.
Confirm the success intubation through end-tidal carbon dioxide on a capnography
The duration of intubation
时间窗: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.
Define as the duration between insertion of lightwand or video-laryngoscope to oral cavity and removal all intubating devices from oral cavity.
次要结局
- number of intubation trial and scooping movements(during intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time)
- Blood pressure change(from start of intubation to 5minute after intubation)
- Postoperative sore throat(at 1hr after PACU arrival and 24hr after operation)
- Postoperative hoarseness(at 1hr after PACU arrival and 24hr after operation)
- Injuries of oral cavity(at immediate after intubation and extubation)
- Heart rate change(from start of intubation to 5minute after intubation)