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RECRUITING
NCT03741777
NA

Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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

Interventions

OTHER

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