The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- airway leak pressure
研究概览
简要总结
Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.
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
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
排除标准
- •Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
结局指标
主要结局
airway leak pressure
时间窗: within 5 min of insertion of each device
Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 30 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
次要结局
未报告次要终点