Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
Healthy Volunteers
ID03741777

Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure

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

288

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying children aged 13 to 17 years who are scheduled for an elective upper gastrointestinal endoscopy to understand how different volumes of clear oral fluids consumed two hours before the procedure affect the residual gastric volume. This study aims to improve fasting guidelines by evaluating the relationship between fluid intake volume and stomach content, helping to optimize preoperative fluid intake to maintain safety and comfort. The study is conducted at Boston Children's Hospital and includes a randomized design with four groups. Participants are randomly assigned to one of four groups, each consuming a different volume of clear fluid (water, pulp-free juice, or tea/coffee without milk) at two hours before surgery: 3 ml/kg, 5 ml/kg, 7 ml/kg, or 10 ml/kg. The study plans to enroll 288 patients in total, with 72 in each group. During the upper GI endoscopy, the actual volume and acidity (pH) of stomach contents will be measured by suctioning the stomach contents. During the study day, researchers will collect demographic data, vital signs, and details about the endoscopy procedure from each participant. The primary outcome is the gastric volume measured from arrival until discharge from the post-anesthesia care unit, up to 24 hours. Secondary outcomes include gastric pH and the incidence of pulmonary aspiration. This information will help establish better fasting guidelines to improve patient hydration and safety before anesthesia.

CONDITIONS

Brief 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 or II
  • Age between 13 and 17 years
  • Scheduled for elective esophago-gastro-duodenoscopy (EGD) procedure
  • First outpatient or inpatient procedure case
  • Fluent in English for participants, families, or guardians
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 hours (before procedure)

Participants drink a specified volume of clear oral fluid (3, 5, 7, or 10 ml/kg) 2 hours before their scheduled elective esophago-gastro-duodenoscopy (EGD) procedure.

1 baseline visit on the day of surgery

Post-operative Follow-up

Duration - Up to 24 hours

Participants are monitored from arrival on the day of surgery until discharge from the post-anesthesia care unit (PACU) for up to 24 hours to measure gastric volume, gastric pH, and incidence of pulmonary aspiration.

Continuous monitoring during hospital stay on surgery day

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

P

Patcharee Sriswasdi, MD, MPH

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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Published Research Related To This Trial

Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration.

https://pubmed.ncbi.nlm.nih.gov/28045707

Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite.

Hanna Andersson, Björn Zarén, Peter Frykholm

https://pubmed.ncbi.nlm.nih.gov/25940831

Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study.

Nils Dennhardt, Christiane Beck, Dirk Huber...

https://pubmed.ncbi.nlm.nih.gov/27291355

Gastric emptying after overnight fasting and clear fluid intake: a prospective investigation using serial magnetic resonance imaging in healthy children.

A Schmitz, C J Kellenberger, R Liamlahi...

https://pubmed.ncbi.nlm.nih.gov/21676893

Tolerance of, and metabolic effects of, preoperative oral carbohydrate administration in children - a preliminary report.

Agnieszka Gawecka, Magdalena Mierzewska-Schmidt

https://pubmed.ncbi.nlm.nih.gov/24858963