A Prospective, Controlled and Randomized Comparison of the Ambu AuraGain and Intersurgical i-Gel Laryngeal Masks in Elective Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure pneumoperitoneum.
研究概览
简要总结
Prospective, controlled, randomized study to compare Ambu AuraGain with Intersurgical i-Gel mask during mechanical ventilation in patients undergoing laparoscopic cholecystectomy.
The investigators hypothesise that when comparing the Ambu® AuraGainTM with Intersurgical i-GelTM mask, the Ambu® AuraGainTM would exhibit a higher oropharyngeal leak pressure (OLP) during mechanical ventilation in patients undergoing laparoscopic cholecystectomy.
The main goal is to compare the Ambu AuraGain with the i-Gel in terms of safety and efficacy during mechanical ventilation in critical phase of the pneumoperitoneum in lateral decubitus and reverse trendelemburg position. Secondary objectives are comparing insertion time, number of attempts, ventilatory airway peak pressure, time and success rates for gastric tube insertion and the incidence of side effects.
详细描述
Design: Prospective, controlled, randomized study. Participants: After approval by the local Clinical Research Ethics Committee, all patients scheduled for elective laparoscopic cholecystectomy at Hospital Plató (Barcelona) will be screened for participation. Patients will be informed about the study and they must provide written consent.
The need for orotracheal intubation during surgery will be considered as a study withdrawal criterion.
The primary outcome is the oropharyngeal leak pressure (OLP).
The secondary outcomes are: insertion time, number of attempts, ventilatory airway peak pressure, time, and success rates for gastric tube insertion and side effects.
Sample size has been calculated to detect a significant difference in oropharyngeal leak pressure (OLP) between two devices. According to the results of previous studies, the investigators assume a mean OLP of 29.2 (3.3) cmH2O for the i-Gel and of 34 (5) cmH2O for the Ambu AuraGain. In order to detect a difference of 10%, assuming a standard deviation of 5 cmH2O for both devices, 44 patients are required per group with a power of 80% and an alpha error of 0.05. To cover against a dropout rate of 10%, a total of 98 patients will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Patients aged 18-80 year
- •American Society of Anaesthesiologists physical status I-III
- •Elective Laparoscopic Cholecystectomy
排除标准
- •Previous knowledge of difficult intubation
- •Mouth opening less than 35 mm
- •Cervical spine disease
- •BMI≥35 kg/m2
- •Upper respiratory or digestive tract disease
- •Severe obstructive pulmonary disease
- •Recent history of upper respiratory tract infection
- •Pregnancy
- •Patients who have a risk of gastric aspiration
- •Preoperative sore throat
- •Patients who refuse to participate
- •Withdrawal criterion:
- •Orotracheal intubation during surgery
结局指标
主要结局
Oropharyngeal leak pressure pneumoperitoneum.
时间窗: 10 month
Oropharyngeal Leak Pressure (OLP) will be measured by closing the expiratory valve of the circle system at a fixed gas flow of 3 litres/min (maximum allowed 40 cmH2O) recording the pressure at which equilibrium has been reached or audible air is leaking.
次要结局
未报告次要终点