Comparison of the Macintosh, King Vision®, Glidescope® and AirTraq® Laryngoscopes in Routine Airway Management
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Time to tracheal intubation
研究概览
简要总结
Failure to successfully intubate the trachea and secure the airway remains a leading cause of morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the concept of endotracheal intubation was developed, 100 years ago the procedure was performed blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization of the larynx with a viewing angle of 15 degrees [5]. Insufficient laryngoscopic view constitutes the main reason for difficult intubations [6].
Video laryngoscopes provide an improved view of the glottis, as the camera is a few millimeters away from the glottis. The use of Glidescope [7-8] and AirTraq [9] laryngoscopes has superior glottis view and ease of tracheal intubation compared with the traditional Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer time to tracheal intubation compared with the traditional techniques which be explained with the variable learning curves of the practitioners. [10]
The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices that claim to provide the "perfect view" for intubation via use of video and digital technology.
The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED light source.
Up to best of the authors' knowledge, there is no current published or ongoing randomized controlled comparative study of the use of King Vision laryngoscope with traditional laryngoscope and other video laryngoscopes for endotracheal intubation.
详细描述
Eighty six ASA I-II patients aged 18-65 years scheduled for elective minor surgery under general anesthesia who need tracheal intubation will be included in this prospective, randomized, single-blind, controlled study at the author's center after obtaining approval of the local ethical committee and an informed written consent from all participants.
Patients will be randomly allocated to one of four groups (n=30 for each) namely, Macintosh, King Vision, Glidescope, or AirTraq groups, by drawing sequentially numbered sealed opaque envelopes containing a software-generated randomization code (Random Allocation Software, version 1.0.0, Isfahan University of Medical Sciences, Isfahan, Iran).
Anesthesia:
The Mallampati airway score, thyromental and sternomental distances with neck extension, and the degree of mouth opening will be evaluated preoperatively as factors predicting difficult intubation. Patients' monitoring includes pulse oximetry, noninvasive blood pressure electrocardiography, state and response Entropy (SE and RE) and train of four (TOF) before induction of anesthesia.
The intubators who will participate in the study received a standardized manikin based training course followed by 10 successful intubations in clinical practice with the use of Macintosh, King Vision®, Glidescope®, and the Airtraq® laryngoscopes for endotracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status class I-II
- •aged 18-65 years
- •scheduled for elective surgery
- •under general anesthesia
排除标准
- •Expected or known difficult airway
- •history of cervical spine injury
- •history of cervical spine surgery
- •previous throat surgery
- •previous oral surgery
- •gastro-esophageal reflux disease
- •pregnancy
- •need for rapid sequence induction
- •emergent surgery
- •body mass index higher than 35 kg/m2
- •Missing incisor teeth
- •Unstable hypertension
- •Unstable coronary artery disease
- •Cerbrovascular disease
结局指标
主要结局
Time to tracheal intubation
时间窗: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds
the time when the investigated laryngoscope passes the central incisors to the time when the tip of the tracheal tube passed through the glottis
次要结局
- duration of laryngoscopy(during laryngoscopy)
- ease of intubation(participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds)
- Hemodynamic parameters(participants will be followed for the duration of laryngeal exposure, an expected average of 90 seconds)
- laryngoscopic view(participants will be followed for the duration of laryngeal exposure, an expected average of 90 seconds)
- number of intubation attempts(participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds)
- number of optimization maneuvers(participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds)