Supreme Laryngeal Mask Use in Urgent Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 584
- 试验地点
- 1
- 主要终点
- First attempt insertion success rate
研究概览
简要总结
The Supreme Laryngeal Mask Airway (SLMA) is a single use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low risk patients undergoing elective Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents.
The primary study hypothesis is the first attempt insertion success rate of SLMA use in urgent Caesarean section.
详细描述
Investigators propose a prospective cohort study to study the first attempt insertion success rate of supreme LMA in general anaesthesia for urgent caesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 50 years old
- •American Society of Anesthesiology status 1 or 2
- •Weight 40 to 75kg
- •Normal airway assessment
- •Term pregnancy (36 weeks or more)
- •Urgent Caesarean Section
排除标准
- •Body mass index (35 or more)
- •Difficult airway (Mallampati 4 or abnormal airway assessment)
- •Gastrooesophageal reflux
结局指标
主要结局
First attempt insertion success rate
时间窗: 1 hour
An attempt is defined as insertion and withdrawal of the device from the patient's airway
次要结局
- Regurgitation(1 hour)
- Aspiration(1 hour)
- Time to effective airway placement(1 hour)
- blood on SLMA on removal(1 hour)
- Sore throat(1 hour)
- Seal pressure(1 hour)
- Gastric aspirate(1 hour)
- Neonatal outcomes(1 hour)
研究者
Wei Yu Yao
Dr
QuanZhou Women and Children's Hospital