A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Glottis View Using the Cormack Lehane Score
研究概览
简要总结
This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used.
The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.
详细描述
Hypothesis
the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA McGrath and Karl-Storz Video-Mac.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a documented body mass index (BMI) of >
- •Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
- •Willingness and ability to sign an informed consent document
- •18 - 80 years of age
- •American Society of Anesthesiologists (ASA) Class II- III adults of either sex.
排除标准
- •Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
- •Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
- •Emergency surgeries
- •Pregnancy
- •The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia.
- •Any other conditions or use of any medication which may interfere with the conduct of the study.
结局指标
主要结局
Glottis View Using the Cormack Lehane Score
时间窗: Up to 1 minute
Cormack Lehane score classification: Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible
Intubation Time Using a Stop Watch
时间窗: up to 3 minutes
Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.
Time to Obtain Glottis Visualization (Seconds)
时间窗: up to 1 minute
It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view. Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery
Percentage of Glottic Opening (POGO) [%]
时间窗: up to 1 minute
POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%. View of the glottic opening (0-100%) during the intubation process.
次要结局
未报告次要终点
研究者
Roya Yumul, M.D.,PhD.
Residency program director, Department of anesthesiology
Cedars-Sinai Medical Center