Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
Boston Children's Hospital · NCT03741777
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 13–17 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 288
- US sites recruiting
- 1
- Study start
- February 29, 2024
- Record last updated
- April 24, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Clear oral fluid
Conditions: Fasting; Gastric Emptying
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Boston Children's Hospital
Boston, MA 01225
Site contact: Patcharee Sriswasdi, MD
Study contacts (from the official record)
- Sirirat Rattanaarpa, MD · 857-218-8020 · sirirat.rattanaarpa@childrens.harvard.edu
- Patcharee Sriswasdi, MD, MPH · 617-599-3679 · patcharee.sriswasdi@childrens.harvard.edu
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