Comparison of oropharyngeal leak pressure of LMA Protector with ProSeal LMA in different head and neck positions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- oropharyngeal leak pressures of LMA protector and PLMA in different head and neck positions
研究概览
简要总结
The oropharyngeal leak pressure is marker of efficacy of supraglottic devices. As the pharyngeal anatomy changes accroding to different head and neck position, the performance of supraglottic device may be affected.Proseal LMA is considered criterion standard supraglottic device and its superiority has been established in terms of better oropharyngeal leak pressure over LMA Classic, LMA Supreme and i gel.Previous studies have suggested that it can be utilized regardless of head and neck position.
We will be comparing oropharyngeal leak pressures of LMA Protector, a new supraglottic device and LMA Proseal in 70 patients scheduled for elective surgeries. Standrad protocol for preanaesthetic surgery will be followed and consent for participation in trial will be taken.On the day of surgery , general anaesthesia will be induced in standard manner. Based on computer generated random table patients will be allocated to one of the two groups; in one group LMA protector will be used and in another LMA Proseal . The primary outcome of study will be comparison of oropharyngeal leak pressure of two devices in neutral, flexion, extension and lateral rotation of head and neck. Number of attempts for sucessful insertion, ease of insertion,laryngeal view on fibreoptic bronchoscopy, ease of insertion of nasogastric tube,, presence of blood on cuff of device after extubation and postoperative sore throat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age>18 years ASA physical status I & II Anticipated duration of surgery≤ 2 hours.
排除标准
- •Known or predicted difficult airway -Patients with pre-existing cervical spine pathology (neck pain or tenderness in cervical spines or associated paraesthesia in upper limbs) -BMI > 35kg/m2 -Thorax, major upper abdomen, Head & neck surgeries -Surgeries requiring lateral or prone positioning -Patient at risk of aspiration such as pregnant patients, those with inadequate fasting, hiatal hernia, gastric outlet obstruction -Mouth opening less than 3 centimetres.
结局指标
主要结局
oropharyngeal leak pressures of LMA protector and PLMA in different head and neck positions
时间窗: after insertion of devices
次要结局
- number of attempts for successful insertion of devices(after insertion of devices)
- time taken for successful insertion of devices(during insertion of devices)
- ease of placement of devices(after placement of devices)
- ease of placement of nasogastric tubes through devices(after placement of devices)
- presence of blood on the cuff of devices(when the device is taken out from patients during extubation)
- postoperative sore throat(1, 2 and 24 hours after surgery)