NCT03741777 Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
| NCT ID | NCT03741777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Fasting |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2024-02-29 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2024-02-29 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Patcharee Sriswasdi, MD, MPH
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT03741777 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Fasting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03741777 currently recruiting?
Yes, NCT03741777 is actively recruiting participants. Contact the research team at sirirat.rattanaarpa@childrens.harvard.edu for enrollment information.
Where is the NCT03741777 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03741777 clinical trial?
NCT03741777 is sponsored by Boston Children's Hospital. The principal investigator is Patcharee Sriswasdi, MD, MPH at Boston Children's Hospital. The trial plans to enroll 288 participants.