Comparative evaluation of Blockbuster laryngeal mask airway and Proseal laryngeal mask airway in patients undergoing laparoscopic appendicectomy under general anaesthesia:A non inferiority randomised controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare oropharyngeal leak pressure of Blockbuster laryngeal mask airway and Proseal laryngeal mask airway in patients undergoing laparoscopic appendicectomy under general anaesthesia
研究概览
简要总结
The developmentof supraglottic airway devices has revolutionized airway management duringgeneral anaesthesia. Theyprovide niche between facemask and tracheal tube. Itprovides less traumatic and less invasive means of securing airway in surgical patients. High SAD (supraglottic airway device)oropharyngeal leakage pressure is required for airway protection duringlaparoscopic surgery, on obese patients and in patients with restrictive lungdisease. If airway sealing is inadequate, theuse of SADs is a potential risk, such as cause gastric insufflations, exposingthe patient to the risk of pulmonary aspiration of gastric content. In this study we will be comparing theoropharyngeal leak pressure of two second generation laryngeal mask airways, BlockbusterLMA(laryngeal mask airway) and Proseal LMA inpatients undergoing laparoscopic appendicectomy under general anaesthesia. A total of 80 patientsof American society of Anaesthesiologists(ASA)physical status I-III of age group 18-60years will be randomly allocated into 2 groups ( group ABlockbuster LMA and group B Proseal LMA) of 40 each.Oropharyngeal leak pressure (OLP),ease of insertion, insertion attempts,insertion time, ease of orogastric tube(OGT) insertion ,fibreopticvisualization of glottis and complications will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA physical status I-III 2.Airway assessment by Malampatti grade I-III 3.Patients undergoing elective laparoscopic appendicectomy under general anaesthesia.
排除标准
- •1.Patient refusal to give consent 2.Anticipated difficult airway(mouth opening<2cm) 3.Upper respiratory tract infection 4.BMI ≥35kg/m² 5.History of radiotherapy of neck 6.Pregnancy 7.Oropharyngeal pathology 8.Previous airway surgeries.
结局指标
主要结局
To compare oropharyngeal leak pressure of Blockbuster laryngeal mask airway and Proseal laryngeal mask airway in patients undergoing laparoscopic appendicectomy under general anaesthesia
时间窗: 10 minutes
次要结局
- To compare both the devices for ease of insertion, time of insertion,number of insertion attempts, ease of orogastric tube placement, fibreoptic visualisation of glottis and perioperative pharyngolaryngeal complications if any(2 hours)