Clinical trial Recruiting at 1 site Observational Ages 2 to 18

Assessing gastric volume and emptying in pediatric surgery patients

Official title: Gastric Assessment of Pediatric Patients Undergoing Surgery

Run by Boston Children's Hospital · NCT05674643 · Data updated 2026-11-12

This study tests if using ultrasound to measure stomach size and how quickly it empties is reliable for kids having surgery, compared to a standard test, to help keep them safe during anesthesia.

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Quick facts

Study typeObservational
Ages2 Years to 18 Years
SexAll
Enrollment60 (estimated)
SponsorBoston Children's Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedFebruary 1, 2023
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedApril 2, 2026
Trial IDNCT05674643 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pediatric patients aged 2 to less than 18 years with ASA classification 1-2 undergoing elective surgery.

Probably not a fit

Patients with a history of gastrointestinal surgery, known GI dysmotility, or those allergic to acetaminophen may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the reliability of gastric ultrasound in measuring gastric volume and emptying in pediatric patients undergoing elective surgery. It will compare ultrasound assessments with the acetaminophen absorption test, a gold-standard method for determining gastric emptying. The study will include two cohorts based on age and anesthesia induction plans, focusing on inter-rater and intra-rater variability in ultrasound measurements. The goal is to enhance pre-operative assessments and improve patient safety during anesthesia.

Why it matters

Potential benefit: If successful, this study could lead to improved pre-operative assessments, reducing the risk of aspiration pneumonia in pediatric patients.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in using ultrasound for gastric assessments, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Boston Children's Hospital
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.