RECRUITING

Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-29
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03741777

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * ASA classification: I and II
  2. * 13-17 years
  3. * IPD cases or the first OPD case
  4. * Scheduled for elective EGD procedure.
  5. * All participants, families or guardians will be fluent in English.
  1. * Emergent EGD procedures
  2. * Patients with active upper GI bleeding
  3. * Patients who received preoperative oral medication
  4. * Patients who are diagnosed as GERD, achalasia or suspected to have gastroparesis status such as uncontrolled diabetes or end stage kidney disease.

Contacts and Locations

Study Contact

Sirirat Rattanaarpa, MD
CONTACT
857-218-8020
sirirat.rattanaarpa@childrens.harvard.edu
Patcharee Sriswasdi, MD, MPH
CONTACT
617-599-3679
patcharee.sriswasdi@childrens.harvard.edu

Principal Investigator

Patcharee Sriswasdi, MD, MPH
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 01225
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Patcharee Sriswasdi, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-29
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-02-29
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • NPO time
  • Gastric content

Additional Relevant MeSH Terms

  • Fasting
  • Gastric Emptying