A randomised comparison of LMA proseal, Ambu auragain, baska mask and LMA protector for airway management in laparoscopic surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
AIM: A Randomized Comparison of LMA Proseal, Ambu Auragain, Baska Mask and LMA Protector for airway management in laparoscopic surgeries
PRIMARY OBJECTIVE:
§ To compare oropharyngeal leak pressure of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laparoscopic surgeries after pneumoperitoneum formation..
SECONDARY OBJECTIVES:
Following are the secondary objectives-
To compare time taken for insertion of LMA proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.
To compare number of attempts of LMA proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.
To compare fiber optic view of glottis through LMA proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.
To compare the hemodynamic changes which are mean arterial pressure and heart rate at different duration of time which are- a. baseline hemodynamics, b. after induction hemodynamics c. after device placement hemodynamics, and d. after removal hemodynamics.
To compare Ease of SAD insertion of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.
To compare success rate of insertion of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.
§ To compare Oropharyngeal leak pressure before pneumoperitoneum formation of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.
To compare complication (including but not limited to sore throat, blood on device, cough etc) between LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.
To compare saturation at different duration of time which are- a. baseline hemodynamics, b. after induction hemodynamics c. after device placement hemodynamics, and d. after removal hemodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •ASA physical status 1 and
- •Elective laparoscopic surgeries of anticipated duration less than 2 hours.
排除标准
- •Anticipated difficult airway.
- •Respiratory and cardiovascular disease.
- •Refusal of consent.
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 20 mins after pneumoperitoneum
次要结局
- time taken for insertion(immediately after device insertion)
- Fibreoptic view of glottis(Intraoperatively after confirmation of adequate ventilation)
- Hemodynamic changes with mean arterial pressure and heart rate.(1. baseline (before induction of anesthesia))
- ease of insertion(Immediately after device placement)
- Success rate of insertion(immediately after device insertion)
- Oropharyngeal leak pressure(after confirmation of correct SAD placement)
研究者
Ayur Verma
King Georges Medical University