Prospective Randomised Trial of the Protector™ Versus the Supreme® Laryngeal Mask Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- OLP
研究概览
简要总结
The goal of this study is to compare the oropharyngeal leak pressure of the Protector Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.
详细描述
The OLP as the primary outcome measurement will be evaluated after insertion of the LMA in each group. We hypothesize that there will be a difference of 4 cm H2O between the 2 masks, because of the different material and slightly different form of the masks. Secondary outcomes will be measured after insertion of the LMA as by protocol. Finally postoperative airway morbidity will be evaluated 3 hours after removal of the LMA.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75
- •Operation on limbs
- •written informed consent
排除标准
- •known difficult airway
- •anatomical abnormalities on airway, Larynx, oesophagus, stomach
- •not fastened
- •high aspiration risk
- •patients with contraindication of laryngeal mask
- •BMI >35 kg/m2
- •patients with disease which impairs accurate Investigation of patient
- •cardiovascular risk factors
- •acute disease where anaesthesia is in doubt
- •no written consent
研究组 & 干预措施
Supreme group
All patients collocated randomly to the Supreme Group, Primary and secondary outcome Parameters are studied
干预措施: Supreme (Device)
Protector group
All patients collocated randomly to the Protector Group Primary and secondary outcome Parameters are studied
干预措施: Protector (Device)
结局指标
主要结局
OLP
时间窗: 5 minutes
oropharyngeal leak pressure
次要结局
- insertion(5 minutes)
- suctioning fluids(5 minutes)
- blood staining(5 minutes)
- Brimacombe score(5 minutes)
- respiratory pressure(5 minutes)
- suctioning catheter(5 minutes)
- CO2(5 minutes)
- airway morbidity(3 hours)
- time of insertion(5 minutes)