NCT05810532已完成不适用
Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
Kangbuk Samsung Hospital2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2023年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Gastric astral cross-sectional area
研究概览
简要总结
Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.
Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).
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)
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children scheduled for elective echocardiography
- •Aged under 3 years old
排除标准
- •Comorbidity other than hear disease or chromosomal disease
- •Patients with delayed gastric emptying
- •Patients with structural abnormalities of the stomach or esophagus
- •Difficult airway management
- •Parents refuse to participate in the study
- •Unable to achieve sedation
结局指标
主要结局
Gastric astral cross-sectional area
时间窗: 10 minutes before sedation
Gastric astral cross-sectional area measured with gastric ultrasound
次要结局
- Estimated gastric volume(10 minutes before sedation)
- Quality of sdeation(10 minutes after sedation)
- Perlas grade(10 minutes before sedation)
研究者
Eunah Cho, MD
Assistant Professor
Kangbuk Samsung Hospital
研究点 (2)
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