NCT04494802Unknown不适用
The Influence of LMA Cuff Pressure on Oropharyngeal Leak Pressure and Gastric Insufflation Assessed by Ultrasound in Pediatric Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 主要终点
- Incidence of gastric insufflation(antrum)
研究概览
简要总结
Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low will not increase gastric insufflation and there is no change in other outcome variables, keeping it low may have a positive effect on anesthesia management and outcome in children.
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
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients undergoing general anesthesia with LMA flexible
排除标准
- •Unstable vital sign, significant arrhythmia or hypotension, Shock
- •anticipated difficult intubation or the patient who have facial deformity
- •high risk of aspiration
- •recent upper respiratory tract infection history
结局指标
主要结局
Incidence of gastric insufflation(antrum)
时间窗: During the surgery(up to 3 hours)
Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound
次要结局
- oropharyngeal leak pressure(During the surgery(up to 3 hours))
- the complication rate(During the surgery and after surgery (up to 6 hours))
- Success rate of insertion of LMA flexible(During the anesthesia induction(up to 1 hour))
- The size of gastric antrum and body(During the surgery(up to 3 hours))
- peak pressure observed before, during, after surgery(During the surgery(up to 3 hours))
- The number and the type of additional manipulation for successful ventilation(During the surgery(up to 3 hours))
- Time for insertion of LMA flexible(During the anesthesia induction(up to 1 hour))
- The number of insertion attempt(During the anesthesia induction(up to 1 hour))
- Ease of insertion of LMA flexible(During the anesthesia induction(up to 1 hour))
- Incidence of gastric insufflation recognized with the ausculation(During the surgery(up to 3 hours))
- Incidence of gastric insufflation(body)(During the surgery(up to 3 hours))
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital
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