Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 920
- 主要终点
- First attempt insertion success rate
研究概览
简要总结
The LMA Supreme (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 Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section.
The primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.
详细描述
We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •ASA 1 or 2
- •Fasted at least 6 hours
- •Weight 40 to 75kg
- •Normal airway assessment
- •Singleton term pregnancy (>36weeks)
- •Elective Caesarean section
排除标准
- •In labour
- •Body mass index >35
- •Difficult airway (Mallampati 4 or abnormal airway assessment)
- •Gastrooesophageal reflux disease
研究组 & 干预措施
Supreme Laryngeal Mask Airway
Supreme Laryngeal Mask Airway (Airway Device) with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.
干预措施: Supreme Laryngeal Mask Airway (Device)
Endotracheal Intubation
Endotracheal intubation (Airway Device) using Macintosh Laryngoscope with tracheal tube with gastric tube insertion after placement. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.
干预措施: Endotracheal intubation (Device)
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 complete withdrawal of the device from the patient's airway
次要结局
- Time to effective airway placement(1 hour)
- Gastric aspirate(1 hour)
- Regurgitation(1 hour)
- Seal pressure(1 hour)
- Aspiration(1 hour)
- blood on SLMA on removal(1 hour)
- Neonatal outcomes(1 hour)
- Sore Throat(1 hour)
- Patient satisfaction(1 hour)
研究者
Wei Yu Yao
Dr
QuanZhou Women and Children's Hospital