Insertion of the ProSeal Laryngeal Mask Airway is More Successful With the 90 Degree Rotation Technique in Pediatric Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Insertion success rate at first attempt
研究概览
简要总结
Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree rotational technique is more successful and causes less pharyngeal trauma than the standard technique in pediatric patients.
详细描述
In our previous series of studies, we introduced a new, simple and effective 90 degree rotational insertion technique and the insertion success rate was great and less pain occurred with the rotational technique in adult. In this study, we investigated whether the 90 degree rotational technique will improve the insertion success rate than the standard technique in pediatric patients.
We hypothesized that the 90 degree rotational technique will improve the insertion success rate and decrease the complication of 2 to 3 size PLMA than the standard index finger insertion technique in children.
One hundred twenty six Asian pediatric patients were randomly allocated to a standard technique group or rotation technique group. The size of the PLMA was from 2 to 3 according to body weight of children. In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique. In the rotation technique group (n = 63), the entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt.
The primary outcome was success at first insertion. Secondary outcome measures were insertion time and complications.
Success at first insertion was significantly higher for the rotation technique than the standard technique, and significantly less time was required. With the rotation technique, the incidence of PLMA repositioning and blood staining was significantly less than for the standard technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asian pediatric patients (age range 3-9 years; American Society of Anesthesiologists physical status I-II) who required general anesthesia with a PLMA for elective surgery.
排除标准
- •Pediatric patient weighed less than 10 kg or over 50 kg, had congenital heart disease, respiratory disease or were at risk of aspiration.
结局指标
主要结局
Insertion success rate at first attempt
时间窗: 5 minute
% of success at first trial
次要结局
- Insertion time, sealing pressure and complication(5 min-4 hrs)