Gastric Assessment of Pediatric Patients Undergoing Surgery

Boston Children's Hospital

Status: Enrolling

Conditions: Delayed Gastric Emptying; Aspiration Pneumonia; Fasting; Respiratory Aspiration of Gastric Content

Treatments: Diagnostic Test: Gastric Ultrasound Serial Scans; Diagnostic Test: Gastric Ultrasound Baseline Scans; Diagnostic Test: Acetaminophen Absorption Test (AAT)

Study type: Observational

Funder types: Other

Identifiers

NCT05674643

IRB-P00040829

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

60 participants in 2 patient groups

Cohort 1 - ultrasound and acetaminophen

Description:

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:

Diagnostic Test: Acetaminophen Absorption Test (AAT)

Diagnostic Test: Gastric Ultrasound Baseline Scans

Diagnostic Test: Gastric Ultrasound Serial Scans

Cohort 2 - ultrasound only

Description:

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:

Diagnostic Test: Gastric Ultrasound Baseline Scans