Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- CSA
研究概览
简要总结
The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.
详细描述
Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.
Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Computerized randomization. Randomization outcome distributed via sealed envelopes. Randomization key stored on secure server.
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia
排除标准
- •Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier
研究组 & 干预措施
4H group
Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction
干预措施: Preoperative fasting instruction (Procedure)
6H group
Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction
干预措施: Preoperative fasting instruction (Procedure)
结局指标
主要结局
CSA
时间窗: Immediately before anesthesia induction
Gastric antral surface area
次要结局
- Suctioned GCV(Immediately after intubation)
研究者
Peter Frykholm
Associate professor
Uppsala University Hospital