Actively Recruiting
Led by Boston Children's Hospital · Updated on 2026-04-02
60
Participants Needed
1
Research Sites
N/A
Total Duration
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
Gastric Assessment of Pediatric Patients Undergoing Surgery
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
J
Jocelyn Booth, BSN
R
Rachel Bernier, MPH
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Adam O Spencer, Andrew M Walker, Alfred K Yeung...
https://pubmed.ncbi.nlm.nih.gov/25495405