Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- The success rate of device insertion
研究概览
简要总结
Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely adopted in the clinical practice.
On the other hand, cricoid pressure has been used to reduce the risk of pulmonary aspiration of gastric contents during induction of general anesthesia. However, cricoid pressure might impede placement of the laryngeal mask airway, thereby preventing effective ventilation.
Recently, left paratracheal pressure was introduced as an alternative to cricoid pressure and reported to be more effective than cricoid pressure in the prevention of gastric air insufflation during positive-pressure ventilation by facemask. Since this method compresses low left paratracheal level, it may affect the successful insertion of laryngeal mask airway.
In this study, the investigators aimed to evaluate the effect of paratracheal esophagus pressure on the insertion of laryngeal mask airway compare to conventional cricoid pressure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The group assignments were sealed in opaque envelopes by a research assistant not involved in the study.
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate
- •American Society of Anesthesiologists Classification 1-2
排除标准
- •Body mass index > 35 kg/m2
- •High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
- •Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),
结局指标
主要结局
The success rate of device insertion
时间窗: During induction of anesthesia, an average of 60 seconds
Successful insertion of laryngeal mask airway in a maximum of three attempts
次要结局
- Success rate in first attempt(: During induction of anesthesia, an average of 60 seconds)
- Incidence of postoperative complications(An average of 2 hours after extubation)
- The time for successful insertion of the device(: During induction of anesthesia, an average of 60 seconds)
- The grade of fiberoptic bronchoscopic view(During induction of anesthesia, an average of 5 minutes)
- The ease of insertion of device(During induction of anesthesia, an average of 60 seconds)
- The presence of gastric air insufflation after induction of anesthesia(During induction of anesthesia, an average of 5 minutes)
- Peak inspiratory pressure(At 5 minute after insertion of laryngeal mask airway)
- The number of attempts at insertion of device(During induction of anesthesia, an average of 60 seconds)
- Incidence of intraoperative complications(During the surgery, an average of 2 hours after anesthesia induction)
研究者
Jong Yeop Kim
Professor
Ajou University School of Medicine