Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Actual intragastric content volume (ml)
研究概览
简要总结
According to normal physiology, the longer fasting period allows food particles to pass stomach through small intestines to minimize intragastric content. The practice guidelines recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. As a result of longer fasting period, patients tend to experience preoperative dehydrated states and intraoperative hypotension. Patients' demographic data will be obtained from charts. Parents will be asked for type, volume of fluid/food intake and NPO time.
This study will be done at BCH's Gastroenterology Procedure Unit (GPU) theaters to measure actual intragastric volume and pH at the beginning esopagogastroduodenoscopy procedures. We hope to demonstrate the relationship between NPO time and actual intragastric volume which provide sufficient data of NPO time to ensure patient's safety.
详细描述
This study is a prospective observational cohort study which will be conducted in 2 parts including preoperative and intraoperative periods.
- Preoperative period, patients' demographic information will be collected along with NPO history including times, type ,amount of preoperative fluid/ food intake and patients' anxiety score.
- Intraoperatively, at the beginning of EGD procedure, total volume of intragastric content(ml) and gastric acidity will be measured.
We plan to offer participation to all patients or parents of patients' ages 0-17 years who are scheduled for EGD at GPU, BCH Longwood campus and are fluent in English. A brochure describing our study in English will be given to patients or their families on the day of surgery. If the patient or family agrees to participate in this study, the study will be provided in the GPU theaters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients who aged 0-17 years scheduled for EGD procedure.
排除标准
- •Patients who required emergency EGD procedures and patients with active upper GI bleeding.
结局指标
主要结局
Actual intragastric content volume (ml)
时间窗: 1 day
Actual intragastric content volume (ml) which is suctioned from each pediatric patient is measured
次要结局
- Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).(1 day)
- Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).(1 day)
- Incidence of perioperative hypotension(1 day)
- Incidence of pulmonary aspiration risk.(1 day)
- Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)(1 day)
- Incidence of surgery delay or cancellation due to NPO guideline violation(1 day)
- Actual pH of intragastric content(1 day)
研究者
Patcharee Sriswasdi
Principal investigator
Boston Children's Hospital