Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology.
Ian Smith, Peter Kranke, Isabelle Murat...
https://pubmed.ncbi.nlm.nih.gov/21712716Preoperative oral fluids: is a five-hour fast justified prior to elective surgery?
J R Maltby, A D Sutherland, J P Sale...
https://pubmed.ncbi.nlm.nih.gov/3767008Low 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/25940831Preoperative fasting for paediatric anaesthesia.
S Phillips, A K Daborn, D J Hatch
https://pubmed.ncbi.nlm.nih.gov/7999497Optimized 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/27291355Gastric 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/21676893Tolerance 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