Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02115
- Boston Children Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All patients who aged 0-17 years scheduled for EGD procedure.
Exclusion Criteria:
- Patients who required emergency EGD procedures and patients with active upper GI bleeding.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Actual intragastric content volume (ml)
大体时间：1 day
|
Actual intragastric content volume (ml) which is suctioned from each pediatric patient is measured
|
1 day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).
大体时间：1 day
|
Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).
|
1 day
|
|
Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).
大体时间：1 day
|
Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).
|
1 day
|
|
Incidence of perioperative hypotension
大体时间：1 day
|
Hypotension is defined as 20% reduction of normal systolic blood pressure for any age groups
|
1 day
|
|
Incidence of pulmonary aspiration risk.
大体时间：1 day
|
Pulmonary aspiration is defined by the regurgitation of gastric contents into the larynx and the respiratory tract and cause a syndrome of progressive dyspnea, hypoxia, bronchial wheeze and patchy collapse, consolidation on chest X-ray or all.
|
1 day
|
|
Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)
大体时间：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
大体时间：1 day
|
Surgery delay is defined when the patient's queue is postponed in order to wait for proper NPO time
|
1 day
|
|
Actual pH of intragastric content
大体时间：1 day
|
Actual pH of intragastric content which is suctioned from each pediatric patient is measured
|
1 day
|
合作者和调查者
调查人员
- 首席研究员：Patcharee Sriswasdi, MD.、Boston Children's Hospital
出版物和有用的链接
一般刊物
- Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Maltby JR, Sutherland AD, Sale JP, Shaffer EA. Preoperative oral fluids: is a five-hour fast justified prior to elective surgery? Anesth Analg. 1986 Nov;65(11):1112-6.
- Andersson H, Zaren B, Frykholm P. Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite. Paediatr Anaesth. 2015 Aug;25(8):770-777. doi: 10.1111/pan.12667. Epub 2015 May 4.
- Phillips S, Daborn AK, Hatch DJ. Preoperative fasting for paediatric anaesthesia. Br J Anaesth. 1994 Oct;73(4):529-36. doi: 10.1093/bja/73.4.529.
- Dennhardt N, Beck C, Huber D, Sander B, Boehne M, Boethig D, Leffler A, Sumpelmann R. Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study. Paediatr Anaesth. 2016 Aug;26(8):838-43. doi: 10.1111/pan.12943. Epub 2016 Jun 13.
- Song IK, Kim HJ, Lee JH, Kim EH, Kim JT, Kim HS. Ultrasound assessment of gastric volume in children after drinking carbohydrate-containing fluids. Br J Anaesth. 2016 Apr;116(4):513-7. doi: 10.1093/bja/aew031.
- Schmitz A, Kellenberger CJ, Liamlahi R, Studhalter M, Weiss M. Gastric emptying after overnight fasting and clear fluid intake: a prospective investigation using serial magnetic resonance imaging in healthy children. Br J Anaesth. 2011 Sep;107(3):425-9. doi: 10.1093/bja/aer167. Epub 2011 Jun 14.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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