The Comparison of Protector LMA and Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia A Randomize Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Ventilatory efficiency pressures for the LMA Protector
研究概览
简要总结
LMA Protector is a recently developed second generation laryngeal mask several kinds of different laryngeal masks were used for the airway management during laparoscopic surgeries. However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery .In this study researchers aim to determine the effectivity of LMA Protector and plan to analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .
详细描述
Tracheal intubation may have more complications than laryngeal masks. In this study researchers aim to determine the effectivity of LMA Protector and on the otherside the heamodynamic variables and the complication rates between tracheal ıntubation and laryngeal mask insertion will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class I-III patients
- •Patients undergo laparoscopic surgeries
- •Laparoscopic surgeries duration of less than 2 hours
排除标准
- •Difficult intubation history
- •Open cholesistectomies
研究组 & 干预措施
LMA Protector Group
LMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale
干预措施: LMA Protector (Device)
Tracheal Intubation Group
Patients will be intubated after standart anesthesia induction and we will record heamodynamic variables. including mean blood pressure and heart rate
干预措施: Tracheal Intubation (Device)
结局指标
主要结局
Ventilatory efficiency pressures for the LMA Protector
时间窗: Intraoperative
Oropharyngeal pressure leak test, the peak airway pressures will be determined
次要结局
- Feasibility of LMA Protector(Intraoperative)
- Ease of insertion of LMA Protector(Intraoperative)
研究者
Ayse Zeynep Turan
Principal Investigator
Derince Training and Research Hospital