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Gastric Assessment of Pediatric Patients Undergoing Surgery

Recruitingn/aAges 2 Years - 18 YearsAllBoston Children's Hospital
NCT05674643 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 assig

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📋 Eligibility rules (as published)
Inclusion Criteria: * Perioperative patients with ASA classification 1-2 * Ages: 2 years- less than 18 years * Locations: Longwood and Waltham campuses of Boston Childrens Hospital Exclusion Criteria: * History of gastrointestinal surgery * Gastrostomy * Known GI dysmotility (cohort 1 only) * Acetaminophen allergy (cohort 1 only) * Liver or renal dysfunction- pre-diagnosed or, if available, when serum biomarkers are 2 standard deviations above the highest value considered normal for age. (cohort 1 only) * Consumption of acetaminophen in the 4 hours prior (cohort 1 only)
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What it tests

  • Gastric Ultrasound Baseline Scans
  • Acetaminophen Absorption Test (AAT)
  • Gastric Ultrasound Serial Scans
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Where

1 site
Boston Children's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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