A Clinical Study of the Setting of Laryngeal Mask Airway Intracuff Pressure Based on Airway Peak Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- The intracuff gas volume after pneumoperitoneum
研究概览
简要总结
The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia and the effects on postoperative complications in the throat. One hundred and twenty patients (American Society of Anesthesiologists grades I or II) scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled in our study. The patients were divided into pressure-regulated group (group P) and control group (group C) randomly. Supreme LMA was inserted in after general anesthesia induction. Air was injected into the cuff to make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth. After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10 cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two groups were recorded, and the leakage rate was calculated as [(VTI-VTE)/ VTI×100%]. Throat complications of all the patients in 24 hours after surgeries were also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with American Society of Anesthesiologists grades I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia
排除标准
- •Patients with limited head and neck activity, limited mouth opening, high abdominal pressure, inflammation of the throat and respiratory diseases
结局指标
主要结局
The intracuff gas volume after pneumoperitoneum
时间窗: Intraoperative
The changes of intracuff gas volume after pneumoperitoneum
The intracuff gas volume before pneumoperitoneum
时间窗: Intraoperative
The changes of intracuff gas volume before pneumoperitoneum
The intracuff pressure before pneumoperitoneum
时间窗: Intraoperative
The changes of intracuff pressure before pneumoperitoneum
The intracuff pressure after pneumoperitoneum
时间窗: Intraoperative
The changes of intracuff pressure after pneumoperitoneum
次要结局
- Throat complications(From the end of operation till 24 hs postoperative)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University
