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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03741777
Status
Recruiting
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Conditions

  • Fasting
  • Gastric Emptying

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Clear oral fluid — OTHER
    clear oral fluid including water, pulp-free juice and tea or coffee without milk.

Study Details

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.

Key Dates

Start date
Feb 29, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 3 ml/kg of clear oral fluid
    This group of patient will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
  • Active Comparator: 5 ml/kg of clear oral fluid
    This group of patient will consume 5 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
  • Active Comparator: 7 ml/kg of clear oral fluid
    This group of patient will consume 7 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
  • Active Comparator: 10 ml/kg of clear oral fluid
    This group of patient will consume 10 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time

Primary Outcome Measure

Gastric volume [ Time Frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts01225
Patcharee Sriswasdi, MD

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By research site
Boston Children's Hospital· Boston, MA

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