Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH

Conditions
-----------------
Fasting, Pediatric ALL

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual intragastric content volume (ml) | Actual intragastric content volume (ml) which is suctioned from each pediatric patient is measured | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between NPO time(hr) and intraoperative intragastric content volume(ml). | Correlation between NPO time(hr) and intraoperative intragastric content volume(ml). | 1 day | 
| Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH). | Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH). | 1 day | 
| Incidence of perioperative hypotension | Hypotension is defined as 20% reduction of normal systolic blood pressure for any age groups | 1 day | 
| Incidence of pulmonary aspiration risk. | 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) | 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 | 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 | Actual pH of intragastric content which is suctioned from each pediatric patient is measured | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPO time, Gastric content, Gastric pH