NCT01133691已完成不适用
Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography
University Children's Hospital, Zurich1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Gastric emptying time
研究概览
简要总结
- Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre.
- Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children.
- Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 6 - 12 years
- •ASA I or II
排除标准
- •gastrointestinal pathology
- •claustrophobia
- •implants like pacemaker, ventriculoperitoneal shunt etc
- •symptomatic or relevant cardiac, renal or metabolic disease
结局指标
主要结局
Gastric emptying time
时间窗: 6 hours
Time after food/fluid ingestion when gastric volume after overnight fast is achieved, as measured by volumetry of magnetic resonance scans
次要结局
- visual analog scale of thirst/hunger(6 hours)
- gastric volume after fasting(6 hours)
- gastric antral area(6 hours)
研究者
研究点 (1)
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