NCT05674643

Gastric Assessment of Pediatric Patients Undergoing Surgery

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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

• Fasting
• Delayed Gastric Emptying
• Aspiration Pneumonia
• Respiratory Aspiration of Gastric Content

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Gastric Ultrasound Baseline Scans	The patient's abdomen will be scanned using the ultrasound device by an expert scanner and novice scanner for baseline assessment of the antral CSA and gastric volume using Perlas US qualitative grading assessment.
DIAGNOSTIC_TEST	Acetaminophen Absorption Test (AAT)	Prior to starting the AAT, a baseline plasma acetaminophen level (250 microliters) will be obtained from the intravenous catheter. The subject will then be given 12.5 mg/kg or max 650mg of single batch 32mg/mL acetaminophen followed by 6oz of water PO. Up to 3 additional small volume blood samples will be drawn for acetaminophen levels. These additional blood samples (250 microliters each) will be obtained to measure acetaminophen plasma levels at the following goal intervals after acetaminophen administration.T1:10-20 mins, T2:35-45 mins, T3: 60mins. At the time of each lab draw gastric ultrasound will be assessed by the expert scanner to correlate gastric ultrasound with the acetaminophen absorption test as a gold-standard of gastric emptying.
DIAGNOSTIC_TEST	Gastric Ultrasound Serial Scans	Cohort 1 will have multiple scans as part of assessing gastric emptying. These sequential scans after the baseline assessment will be done in line with the Acetaminophen Absorption Test timeline (T1:10-20 mins, T2:35-45 mins, T3: 60mins) and will be performed by an expert scanner only.

Timeline

• Start date: 2023-02-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2023-01-06
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States