Initial Experience With Storz C-MAC Video Intubation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time for Intubation
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of the C-MAC (Karl Storz Endoscopy, Inc., Tuttlingen, Germany) video intubation system guided intubation techniques.
We hypothesize that the C-MAC video laryngoscope is safe and efficacious in terms of successful endotracheal intubation. The C-MAC may be a safe and suitable alternative device for routine and difficult laryngoscopy and tracheal intubation. This is the first study to investigate the performance of C-MAC in clinical practice.
详细描述
Since the introduction of the laryngoscope into clinical anesthesia practice, innovators have attempted to improve upon and perfect the design of the laryngoscope blade. The goal of these innovations has been to improve visualization of laryngeal structures and increase the likelihood of successful tracheal intubation.
It is estimated that endotracheal intubation is performed on some 8 million patients per year in the United States. Of these endotracheal intubations, approximately 80% are performed by direct laryngoscopy with transoral placement of the endotracheal tube (ET) into the trachea. The incidence of unsuspected difficult intubation is estimated to be higher at approximately 3%. One factor that contributes to difficult intubation is poor visualization of the airway.
Video laryngoscopes are a relatively new edition to the armamentarium of airway devices available to the airway manager. Although these instruments are more expensive than traditional direct laryngoscopes, they offer several advantages that may justify their expense. While many clinicians may espouse the routine use of video laryngoscopy, most providers advocate its use for anticipated difficult situations, or as "plan B" after failed intubation by direct laryngoscopy (DL).
The video laryngoscopes have been shown to provide superior views to traditional laryngoscopy in normal and difficult intubation situations.3-6 Video intubation techniques, by allowing tracheal intubation monitoring, improve the safety of the procedure and increase intubation success. In contrast, using conventional laryngoscopy, anesthesiologists have only a "keyhole" view of the airway structures; a view that may be further obscured during attempts to pass the ET tube.
The C-MAC video laryngoscope is the latest edition to the pool of video laryngoscopes. C-MAC is a further development of the V-MAC (Karl Storz Endoscopy, Inc., Tuttlingen, Germany) video laryngoscope. The C-MAC became commercially available in US in March 2009 and at this time; there are no studies available regarding its use in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- 是
入选标准
- •Age 18 - 80 years of age
- •ASA I - III
- •Mallampati I-III
- •Mouthopening > 4cm
排除标准
- •Age < 18 years and > 80 years of age
- •ASA IV - V
- •Mallampati IV - V
- •Mouthopening < 4cm
结局指标
主要结局
Time for Intubation
时间窗: at the time of intubation (about 10 seconds)
Time taken for successful placement of endotracheal tube (that is, intubation).
次要结局
- Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)(at the time of laryngoscopy (about 10 seconds))
- Number of Participants With Successful Intubation(at the time of intubation (about 10 seconds))
- Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)(at the time of laryngoscopy (about 10 seconds))
- Ease of Laryngoscopy as Assessed by a Rating Scale(at the time of laryngoscopy (about 10 seconds))
- Laryngoscopy Time(at the time of laryngoscopy (about 10 seconds))
- Ease of Intubation as Assessed by a Rating Scale(at the time of intubation (about 10 seconds))
研究者
Davide Cattano
Associate Professor - Anesthesiology
The University of Texas Health Science Center, Houston