Does King Vision® Videolaryngoscope Reduce Cervical Spine Motion During Endotracheal Intubation? A Cross-over Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- cervical spine movement
研究概览
简要总结
Extensive cervical spines movement during endotracheal intubation can result in serious neurological injury, especially in the patients with unrecognized cervical spines injury.[1-2] Moreover, direct laryngoscopy may be difficult if spine movement is limited because of arthritis, disc disease or a small gap between the occiput and the spinous process of the atlas.[3-4]
Video laryngoscopes allow for intubation without alignment of the oral, pharyngeal, and tracheal axes which minimize the cervical movements, especially in the patients with restricted cervical movements. [5,6] Compared with the Macintosh laryngoscope, the use of AirWay Scope decreases median upper cervical-spine movement during intubation under in-line stabilization in patients with normal cervical-spine. [6] Unfortunately, the use video laryngoscopes are associated with longer times to tracheal intubation compared with the traditional techniques which may be attributed to the variable learning curves of the practitioners. [7-9]
The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is an anatomically shaped, rigid laryngoscope that uses fiberoptic technology to view the larynx with micro camera offers a 160 degree of view potentially eliminating the need for neck flexion and head extension. [10]
To the best of the authors' knowledge, there is no study has evaluated the King vision laryngoscope regarding the neck movement during routine tracheal intubation under general anesthesia.
详细描述
Hypothesis:
The investigators hypothesize that the use of King Vision video laryngoscope may reduce the cervical spines movements during endotracheal intubation compared with the Macintosh laryngoscope.
Aim of the study:
The present clinical trial aims to compare the effects of the Macintosh and King Vision laryngoscopes, on cervical spines movement, time to intubation, laryngoscopic view, ease of intubation, number of intubation attempts, and number of optimization maneuvers during tracheal intubation, in the patients undergoing minor elective surgery under propofol-remifentanil-rocuronium anesthesia.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixteen American Society of Anesthesiologists physical status class I-II
- •aged 18-65 years
- •scheduled for elective minor surgery
- •under general anesthesia
排除标准
- •predicted or known difficult airway
- •history of cervical spine injury
- •history of cervical spine surgery
- •previous oral surgery
- •previous throat surgery
- •previous neck surgery
- •gastro-esophageal reflux disease
- •need for rapid sequence induction
- •emergent surgery
- •pregnancy
- •body mass index higher than 35 kg/m2
- •without incisor teeth
结局指标
主要结局
cervical spine movement
时间窗: Participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
cervical spine movement during tracheal intubation
次要结局
- time to intubation(participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds)
- ease of intubation(participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds)
- number of intubation attempts(participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds)
- laryngoscopic view(participants will be followed for the duration of laryngoscopy, an expected average of 90 seconds)
- number of optimization maneuvers(participants will be followed for the duration of laryngoscopy, an expected average of 90 seconds)