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

NCT03741777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Fasting
  • Gastric Emptying

Interventions

OTHER

Clear oral fluid

clear oral fluid including water, pulp-free juice and tea or coffee without milk.

Sponsors & Collaborators

Principal Investigators

  • Patcharee Sriswasdi, MD, MPH · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03741777 on ClinicalTrials.gov