Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
Sponsor: Boston Children's Hospital
Summary
According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake. This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure. The investigators believe that the information from this study will help establish a comprehensive NPO guideline.
Official title: Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure
Key Details
Gender
All
Age Range
13 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2024-02-29
Completion Date
2025-12
Last Updated
2024-06-26
Healthy Volunteers
Yes
Conditions
Interventions
Clear oral fluid
clear oral fluid including water, pulp-free juice and tea or coffee without milk.
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States