Comparing how different amounts of clear fluids affect stomach contents in children before surgery
Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure
This study is testing how different amounts of clear fluids before surgery can affect the stomach contents of children aged 13 to 17 to find the best way to keep them hydrated and safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03741777 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of varying volumes of clear oral fluids on residual gastric volume in children aged 13 to 17 years scheduled for elective upper GI endoscopy. Participants will be randomly assigned to consume different amounts of clear fluids (3, 5, 7, or 10 ml/kg) two hours prior to their procedure. The goal is to optimize preoperative hydration while minimizing the risk of pulmonary aspiration. Data on demographics and vital signs will be collected to assess the outcomes of the different fluid volumes.
Who should consider this trial
Good fit: Ideal candidates are children aged 13 to 17 years who are classified as ASA I or II and scheduled for elective upper GI endoscopy.
Not a fit: Patients undergoing emergency procedures or those with active upper GI bleeding or specific gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish optimal fluid intake guidelines for children before surgery, improving patient safety and comfort.
How similar studies have performed: While there is existing literature on fasting guidelines, this specific approach to varying fluid volumes in pediatric patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Patcharee Sriswasdi, MD, MPH — Boston Children's Hospital
- Study coordinator: Sirirat Rattanaarpa, MD
- Email: sirirat.rattanaarpa@childrens.harvard.edu
- Phone: 857-218-8020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.