The Laryngeal Mask Airway Supreme (TM) is an Effective Alternative to Laryngoscope-guided Tracheal Intubation for Patients Undergoing Elective Laparoscopic Cholecystectomy-- A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Time to Effective Airway
研究概览
简要总结
We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.
详细描述
The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status 1 and 2
- •Undergoing elective laparoscopic cholecystectomy
排除标准
- •BMI > 30
- •Known gastro-oesophageal reflux disease
- •predicted or documented difficult airway
- •contraindications to drugs in the standardized anaesthesia protocol
结局指标
主要结局
Time to Effective Airway
时间窗: Baseline
Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation
次要结局
- Number of attempts taken for successful placement of airway device(Baseline)
- Peak airway pressure during pneumoperitoneum(Assessed intra-operatively, during the period of pneumoperitoneum)
- Incidence of post-operative sore throat(Assessed 1 hr after the surgery, at the Recovery Area)
- Number of attempts taken for successful placement of gastric tube(Baseline)
- Haemodynamic response to insertion of airway device(Baseline, 1 min, 5 min)
研究者
Kelvin Quek How Yow
Consultant Anaesthetist
Changi General Hospital