Gastric Ultrasound Assessment of Two Preoperative Fasting Regimens in Pediatric Patients: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- proportion of patients with a risky stomach.
研究概览
简要总结
The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries
详细描述
it is unknown how many patients have gastric volumes that place them at increased risk of aspiration despite adequate fasting.
There is a growing interest in the use of bedside ultrasonography to assess gastric content and volume. It has been suggested that the gastric antrum in particular can be assessed reliably by sonography.
hence, this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to detect accuracy of preoperative fasting hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •paediatric patients aged 6-12 years old
- •ASA physical status I and II
- •scheduled for elective surgeries
- •the anticipated duration of 30-60 min
排除标准
- •parents' refusal
- •overweight or obesity
- •expected difficult airway management
- •increased abdominal pressure
- •diabetes mellitus
- •congenital diseases
- •GERD or esophageal disease
- •uncooperative patients,
- •mental retardation or neurological disease
- •upper airway surgeries.
结局指标
主要结局
proportion of patients with a risky stomach.
时间窗: immediately preoperative
bedside ultrasound to estimate the gastric volume in milliliter
次要结局
- parents satisfaction(after PACU discharge (within 2 hours postoperative))
- episodes of gastric regurgitation, vomiting , aspiration(during induction or emergence from anesthesia (within 30 minutes))
- cancellation(decision will be taken within 30 minutes preoperative)
- adverse events(preoperative or postoperative)
- gastric volume(immediately preoperative (within 30 minutes))
- gastric content quality(immediately preoperative)
- type of last meal(last meal within 24 hours preoperative)
- fasting hours(the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids))
研究者
Mona Raafat Elghamry
principal investigator
Tanta University