A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Insertion Time
研究概览
简要总结
Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.
The research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 75 years
- •ASA I and II
- •Mallampatti class: I and II
- •Thyromental distance > than 6.5 cm
- •Interincisor distance > than 3 cm
- •BMI < 35 Kg/m2
- •Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal surgical procedures in supine position
排除标准
- •Weight < 50 kg
- •BMI > 35 Kg/m2
- •Pregnant patients
- •Known or expected difficult airway
- •Patients with active, untreated and unresolved gastroesophageal reflux
- •Esophageal pathology, pulmonary pathology
- •Laparoscopic procedures
- •ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure
结局指标
主要结局
Insertion Time
时间窗: During intubation of the patient
The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.
次要结局
- Insertion Success Rate(During intubation of the patient)
研究者
Sonia Vaida
M.D, Vice Chair for Research
Penn State University