Taking people in United StatesNo phase

Checking stomach emptying with ultrasound in children having surgery

Tests how reliably ultrasound measures stomach contents in children before surgery.

Key facts

Who runs it: Boston Children's Hospital
Where: Boston, United StatesSee the site
Trial code: NCT05674643
Registry title: Gastric Assessment of Pediatric Patients Undergoing Surgery
Status: Recruiting
People taking part: 60 people, planned
Started: 1 Feb 2023
Expected to end: 31 Dec 2028
Type of study: Observational, 2 groups
Treatments tested: Gastric Ultrasound Baseline Scans
Acetaminophen Absorption Test (AAT)
Gastric Ultrasound Serial Scans
Record updated: 2 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 2 to under 18 who are having planned surgery under general anesthesia at Boston Childrens Hospital (Longwood and Waltham campuses). It uses stomach ultrasound, and some children also take an acetaminophen test.

Age: 2 years to less than 18 years
Sex: All sexes
Disease stage: Children who are generally healthy or have only mild illness (ASA class 1-2) and are having surgery.
Earlier treatment: Children who have had stomach or bowel surgery cannot join.

Main reasons for not taking part

Past stomach or bowel (gastrointestinal) surgery
A feeding tube placed into the stomach (gastrostomy)
Cohort 1 only: known problems with how the gut moves food, or allergy to acetaminophen
Cohort 1 only: liver or kidney problems, known before or seen in blood tests
Cohort 1 only: took acetaminophen in the 4 hours before

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

Perioperative patients with ASA classification 1-2
Ages: 2 years- less than 18 years
Locations: Longwood and Waltham campuses of Boston Childrens Hospital

Who cannot take part

Consumption of acetaminophen in the 4 hours prior (cohort 1 only)
History of gastrointestinal surgery
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)
Gastrostomy
Known GI dysmotility (cohort 1 only)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 2 and 18 years old?

Where in United States

Boston Children's HospitalBoston, United StatesContact: Jocelyn Booth, BSNTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The 2 groups in the trial

Cohort 1 - ultrasound and acetaminophen
Cohort 1 will include subjects who have a peripheral intravenous line placed in the pre-op area per routine care. This cohort is on average age 7 years and older. Procedures for cohort 1 will include: (a) gastric US measurement of the antral CSA and gastric volume using the Perlas US qualitative grading assessment by an expert and a novice operator to determine the inter-rater class reliability and repeat measurements by each operator to assess the intra-rater reliability (Aim 1), and (b) serial abdominal ultrasounds for gastric assessment and the acetaminophen absorption test to determine the correlation between gastric US and a gold-standard for gastric emptying (Aim 2). The acetaminophen absorption test requires administering a single weight-based enteral dose of acetaminophen with 6 oz of water and drawing of blood samples through a peripheral intravenous line.
Treatment: Gastric Ultrasound Baseline Scans, Acetaminophen Absorption Test (AAT), and Gastric Ultrasound Serial Scans
Cohort 2 - ultrasound only
Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Average age for cohort 2 is age less than 7 years old. Procedures for Cohort 2 will include a gastric US measurement of the antral CSA and gastric volume using Perlas US qualitative grading assessment by an expert and a novice operator to determine the inter-rater class reliability and repeat measurements by each operator for the intra-rater reliability (Aim 1). This cohort is included to examine the reliability of measurements across age groups.
Treatment: Gastric Ultrasound Baseline Scans