Comparative evaluation of efficacy of two anatomically preformed supraglottic airway devices for ventilation in adult patients undergoing elective surgery under general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
The supraglottic airway device is commonly used for airway management during anaesthesia or as an immediate life saving measurement in patients with difficult or failed airway. The laryngeal mask protector(LMA Protector) is a new second generation supraglottic airway device made with medical grade silicon. The LMA protector provides access tp and functional separation of the ventilation and digestive tract, with the presence of two drainage channels, which emerge proximally as separate ports and enter the chamber located behind th cuff bowl. Ambu AuraGain is a well established second generation supraglottic airway device. It has noninflatable gel like cuff made up of medical grade thermoplastic elastomer and designed to anatomically fit the peri laryngeal structures to provide effective seal.
This study will compare LMA Protector and Ambu AuraGain, mainly on the basis of the oropharyngeal leak pressure, also compares other parameters during the insertion of these devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •This study will be conducted in adult patients , in age group 18 to 65 years, weighing 30 to 70 kg, ASA physical status I and II undergoing elective surgery under general anaesthesia with controlled ventilation in supine position.
排除标准
- •Patients with anticipated difficult airway 2)Mouth opening less than 3.5cm, BMI more than 30kg/m2 3)Cervical spine pathology 4)Intestinal and oesophageal pathology 5)Operation time greater than 4 hours 6)High risk of aspiration 7)Cardiac and pulmonary compromise, Hypertension 8)Poor dentition with high risk of damage 9)Pregnancy.
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: after device insertion
次要结局
- Number of attempts taken for successful insertion of device, Time for achieving effective ventilation, Number of patients requiring manipulation for achieving effective ventilation and type of manipulation, Ease of insertion of device, Ease of gastric catheter insertion, Score regarding anatomical alignment of device(At the time of device insertion.)