Study of Ultrasound and Acetaminophen Tests to Measure Stomach Emptying in Children Ages 2 to 18 Undergoing Surgery
Led by Boston Children's Hospital · Updated on 2026-04-02
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the consistency and accuracy of gastric volume and emptying measurements using gastric ultrasound in children undergoing general anesthesia for elective surgery. The study aims to determine how well different operators agree on ultrasound measurements and how these measurements compare to a gold-standard test called the acetaminophen absorption test. Two groups of children are studied based on age and anesthesia method to explore these questions across different age ranges and clinical procedures.
The study involves two groups Cohort 1 includes children aged 7 years and older who receive an intravenous induction of anesthesia. These children will have abdominal ultrasounds as well as the acetaminophen absorption test, which involves giving an oral dose of acetaminophen with water and drawing blood samples to measure acetaminophen levels. Cohort 2 includes children younger than 7 years who do not routinely have an intravenous line placed. These children will have ultrasound assessments only. Both cohorts undergo ultrasound scans performed by expert and novice operators to assess measurement reliability.
Participants will be involved in ultrasound assessments of the stomach before and during anesthesia. Cohort 1 will have multiple ultrasound scans aligned with blood sample collections at specific times after acetaminophen administration to study gastric emptying. Researchers will evaluate how consistent measurements are between different operators and within the same operator over time. They will also compare ultrasound results to acetaminophen absorption results as the main measure of gastric emptying. Safety and outcomes after anesthesia will also be monitored. Participation duration varies depending on the cohort and procedures performed.
CONDITIONS
Brief Title
Gastric Assessment of Pediatric Patients Undergoing Surgery
Research Team
J
Jocelyn Booth, BSN
R
Rachel Bernier, MPH
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Perioperative patients with ASA classification 1-2
Ages 2 years to less than 18 years
Planned surgery at specified Boston Children's Hospital campuses
You will not qualify if you...
History of gastrointestinal surgery
Presence of gastrostomy
Known gastrointestinal motility problems (cohort 1 only)
Allergy to acetaminophen (cohort 1 only)
Liver or kidney dysfunction based on diagnosis or abnormal lab values (cohort 1 only)
Acetaminophen consumption within 4 hours prior to study (cohort 1 only)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo gastric ultrasound scans to assess antral cross-sectional area and gastric volume, performed by both expert and novice operators to evaluate measurement reliability. Cohort 1 participants also receive the acetaminophen absorption test involving a single dose of acetaminophen with serial blood draws to assess gastric emptying.
1 baseline visit and up to 3 additional assessment visits depending on cohort assignment
Long-term Monitoring
Duration - 1 year
Participants are followed for up to 1 year to assess inter-rater and intra-rater reliability of measurements, gastric emptying, and post-anesthetic outcomes.
Periodic assessments as part of follow-up
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes.
Adam O Spencer, Andrew M Walker, Alfred K Yeung...