Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
Healthy Volunteers
NCT03741777

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

Led by Boston Children's Hospital · Updated on 2026-04-24

288

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 13Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA classification I and II
  • Aged 13 to 17 years
  • Inpatient cases or first outpatient cases
  • Scheduled for elective esophago-gastro-duodenoscopy (EGD) procedure
  • Participant, family, or guardian fluent in English
Not Eligible

You will not qualify if you...

  • Emergency EGD procedures
  • Active upper gastrointestinal bleeding
  • Received preoperative oral medication
  • Diagnosed with GERD, achalasia, or suspected gastroparesis such as uncontrolled diabetes or end-stage kidney disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 01225

Actively Recruiting

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Research Team

S

Sirirat Rattanaarpa, MD

CONTACT

P

Patcharee Sriswasdi, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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