Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients - A Prospective Randomized Crossover Trial
试验速览
- 阶段
- 4 期
- 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 investigators hypothesize that the D-MAC (Dblade with C-MAC system) may be a suitable alternative device for difficult laryngoscopy and tracheal intubation in morbidly obese patients. The D-MAC will enable superior view of the glottic structures as well as easier endotracheal intubations than the C-MAC blade. This is the first study to investigate the individual and comparative performances of C-MAC and D-MAC in this patient cohort.
详细描述
Since the introduction of laryngoscopy, blades have undergone design innovations with the goal of improving laryngeal visualization and successful tracheal intubation because difficult intubation may be encountered even in patients with favorable anatomy.
Failed intubation shows occurrence in 0.05% of surgical patients and in 0.13% to 0.35% of obstetric and obese patients and the incidence of unsuspected difficult intubation is estimated to be higher at approximately 3%, with poor airway visualization being a major contributing factor.
Moreover airway management in the obese patient population requires special consideration. An increased BMI is associated with reduced posterior airway space and improper mask ventilation, both of which may lead to rapid development of hypoxemia and possible desaturation immediately after anesthetic induction.
As the prevalence of obesity has increased from 23% in 1992 to 33.8% in 2008 and an estimated 140,000 surgical bariatric cases are performed in the U.S., anesthesiologists face challenges of airway management in this population.
The main advantage of video intubation is provision of superior views compared to traditional laryngoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Age 18-65 years
- •ASA I-III
- •BMI ≥ 40 kg/m2
排除标准
- •Necessary awake intubation
- •Mallampati IV
- •< 2 finger breath or 4 cm mouth opening
- •Previous history of difficult intubation
- •Unstable cervical, thoracic and/or lumbar fracture
- •Known history of congestive heart failure or a severe disease that alters pulmonary mechanics (e.g. chronic obstructive pulmonary disease, restrictive lung diseases)
结局指标
主要结局
Time for Intubation
时间窗: 90 seconds
Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.
次要结局
- First Laryngoscopy(30 seconds)
- Second Laryngoscopy(30 seconds)
研究者
Davide Cattano
Associate Professor
The University of Texas Health Science Center, Houston