Recruiting

Fluid Intake

Sponsor:

Boston Children's Hospital

Code:

NCT03741777

Conditions

Fasting

Gastric Emptying

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

Interventions

Clear oral fluid

Study Details

Brief 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

Study ID

NCT03741777

Start date

Feb 29, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ASA classification: I and II
  • 13-17 years
  • IPD cases or the first OPD case
  • Scheduled for elective EGD procedure.
  • All participants, families or guardians will be fluent in English.

Exclusion Criteria:

  • Emergent EGD procedures
  • Patients with active upper GI bleeding
  • Patients who received preoperative oral medication
  • Patients who are diagnosed as GERD, achalasia or suspected to have gastroparesis status such as uncontrolled diabetes or end stage kidney disease.

Study Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 3 ml/kg of clear oral fluid

This group of patient will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time

active comparator: 5 ml/kg of clear oral fluid

This group of patient will consume 5 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time

active comparator: 7 ml/kg of clear oral fluid

This group of patient will consume 7 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time

active comparator: 10 ml/kg of clear oral fluid

This group of patient will consume 10 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time

Interventions

Clear oral fluid

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

Primary outcome measure

  • Gastric volume [ Time Frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours ]

Central Contacts and Locations

Central contacts

Sirirat Rattanaarpa, MD

857-218-8020sirirat.rattanaarpa@childrens.harvard.edu

Patcharee Sriswasdi, MD, MPH

617-599-3679patcharee.sriswasdi@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 01225

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • NPO time
  • Gastric content

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-04-24.