A Randomised Comparative study to evaluate the performance of Ambu Auragain and the Laryngeal Mask Airway Supreme in Adult patients for Elective surgeries under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure(in cm H2O)
研究概览
简要总结
Supraglottic Airway devices form a bridge between the mask and endotracheal intubation. Following the introduction of LMA , numerous advances have been made with respect to design and safety features. The LMA Supreme and Ambu Auragain are the new second generation SGADs having comparable features such as inflatable cuff, a preformed anatomical curvature facilitating easy insertion and a gastric port for Nasogastric tube insertion and produces high OLP facilitating positive pressure ventilation. Previous studies have reported conflicting results regarding performance of these 2 devices. We are conducting this study to compare insertion of the device, OLP, ease of NGT insertion, hemodynamic stability and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant and Outcome Assessor 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
- •Duration of surgeries less than 2 hours ASA I and II Posted for elective surgery under general anaesthesia in supine position.
排除标准
- •Patients with predicted difficult airway Patients with any pathology in neck, upper respiratory or alimentary tract BMI more than 30kg/me Patients with history of obstructive sleep apnea,lung diseases or bleeding disorders Patients with full stomach or history of oesophageal reflux Pregnancy.
结局指标
主要结局
Oropharyngeal leak pressure(in cm H2O)
时间窗: Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
Ease of insertion of Nasogastric tube
时间窗: Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
Number of attempts, time taken for insertion(in seconds) and ease of insertion
时间窗: Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
Hemodynamic changes(heart rate, saturation and blood pressure)
时间窗: Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
次要结局
- Intraoperative desaturation or laryngospasm(Blood stain on device during withdrawal)