Actively Recruiting
Gastric Assessment of Pediatric Patients Undergoing Surgery
Led by Boston Children's Hospital · Updated on 2026-04-02
60
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this pilot prospective cohort study is to examine the reproducibility of gastric volume and emptying as measured by gastric ultrasound and its correlation to a gold-standard test for gastric emptying in the perioperative period in pediatric patients. The main questions it aims to answer are: * What is the reliability (inter-rater variability between expert and novice assessors, and intra-rater variability) of a) the gastric antral cross-sectional area (CSA) and b) gastric volume using the Perlas US qualitative grading assessment, measured by using an ultrasound device in pediatric patients undergoing general anesthesia for elective surgery? * What is the correlation between ultrasound assessment of gastric emptying by the antral-CSA and gastric emptying determined by the acetaminophen absorption test (AAT), the gold standard? The study will include two cohorts. Cohort assignment will be based on age and anesthesia induction plan. Subjects \>7yrs of age and expected to get an IV induction will be assigned to Cohort #1. Subjects \<7yrs of age and not expected to get an IV induction will be assigned to Cohort #2. * Cohort 1 will include abdominal ultrasound for gastric assessment AND the acetaminophen absorption test which includes administering enteral acetaminophen (tylenol) with 6 oz of water and drawing of blood samples through a peripheral intravenous line. * Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Procedures for Cohort 2 will include abdominal ultrasound only in the pre-op area (no tylenol). This cohort is included to examine the reliability of measurements across age groups.
CONDITIONS
Official Title
Gastric Assessment of Pediatric Patients Undergoing Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Perioperative patients with ASA classification 1-2
- Ages 2 years to less than 18 years
- Patients treated at Longwood and Waltham campuses of Boston Children's Hospital
You will not qualify if you...
- History of gastrointestinal surgery
- Presence of gastrostomy
- Known gastrointestinal dysmotility (for cohort 1 only)
- Allergy to acetaminophen (for cohort 1 only)
- Liver or renal dysfunction diagnosed or indicated by abnormal serum biomarkers (for cohort 1 only)
- Consumption of acetaminophen within 4 hours prior to study (for cohort 1 only)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
J
Jocelyn Booth, BSN
CONTACT
R
Rachel Bernier, MPH
CONTACT
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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