Comparative evaluation of Proseal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.To compare the oropharyngeak leak pressure ofProSeal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation .
研究概览
简要总结
This study is prospective,randomized,parallel group,active control trial where two devices Gnana LA II and Proseal laryngeal mask airway will be used for maintainence of airway during general anesthesia.These devices will be compared primarily in terms of oropharyngeal leak pressure(OLP),which signifies the efficacy of seal offered around laryngeal outlet.Secondary outcome measures will compare the overall efficacy of Gnana LA II and Proseal laryngeal mask airway by comparing the ease of insertion,fiberoptic visualization,hemodynamic and ventilatory parameters in paralysed patients undergoing elective surgery with controlled ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 18 to 60 years
- •American Society of Anaesthesiologist (ASA) physical status I and II.
- •Patients scheduled for elective surgery under general anaesthesia (Duration of surgery 2 ± 0.5 hrs).
排除标准
- •Patients with anticipated difficult airway (Airway Difficulty Score>8).22
- •Patients with upper respiratory tract infection
- •Patients with increased risk of regurgitation and aspiration of gastric content
- •Patients with a body mass index (BMI) > 35 kg.m.-2
- •Patients with past history of radiotherapy to the neck involving the hypopharynx
- •Patients undergoing surgeries involving neck and oral cavity
- •Pregnant patients.
结局指标
主要结局
1.To compare the oropharyngeak leak pressure ofProSeal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation .
时间窗: immediately after the placement of device.
次要结局
- 2.To evaluate the efficacy of ProSeal laryngeal mask airway with Gnana laryngeal airway II for(device insertion success,)