A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- the sizes of the PLMA determined with the ear-based formula
研究概览
简要总结
After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I/II
- •scheduled for genitourinary operation
- •LMA was indicated for anesthesia
排除标准
- •surgery lasting more than 3 h
- •overweight or underweight patients
- •gastroesophageal reflux
- •risk of aspiration
- •airway infection in the last six weeks
- •decreased pulmonary or chest wall compliance.
研究组 & 干预措施
Ear-sized based and weight based formula
the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula
干预措施: Ear-sized based (Device)
结局指标
主要结局
the sizes of the PLMA determined with the ear-based formula
时间窗: One year
we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA
次要结局
未报告次要终点
研究者
Murat Haliloglu
Medical doctor
Yeditepe University Hospital