Gastric Assessment of Pediatric Patients Undergoing Surgery
- Conditions
- Respiratory Aspiration of Gastric ContentFastingDelayed Gastric EmptyingAspiration Pneumonia
- Interventions
- Diagnostic Test: Gastric Ultrasound Baseline ScansDiagnostic Test: Acetaminophen Absorption Test (AAT)Diagnostic Test: Gastric Ultrasound Serial Scans
- Registration Number
- NCT05674643
- Lead Sponsor
- Boston Children's Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Perioperative patients with ASA classification 1-2
- Ages: 2 years- less than 18 years
- Locations: Longwood and Waltham campuses of Boston Childrens Hospital
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 - ultrasound and acetaminophen Gastric Ultrasound Baseline Scans 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. Cohort 1 - ultrasound and acetaminophen Gastric Ultrasound Serial Scans 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. Cohort 2 - ultrasound only Gastric Ultrasound Baseline Scans 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. Cohort 1 - ultrasound and acetaminophen Acetaminophen Absorption Test (AAT) 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.
- Primary Outcome Measures
Name Time Method Intra-rater reliability 1 year Measured using the following quantitative and qualitative ultrasound assessments between a novice and an expert gastric ultrasound operator:
* Qualitative using the previously published Perlas' US qualitative grading assessment
* Grade 0- no contents visualized in supine and lateral position
* Grade 1- contents visualized in the lateral decubitus position (RLD) only
* Grade 2- contents visualized in the supine and RLD.
* Quantitative assessment using the cross-sectional area as published by Spencer AO et al.
* Measurement of the CSA: longitudinal diameter (D1), and the antero-posterior diameter (D2) in both supine and RLD. Then these will be used to calculate the cross-sectional area (CSA) = (π\*D1\*D2)/4.Gastric Emptying 1 year Outcome will be gastric emptying assessed by the change in antral CSA (measured in cm2) over time after acetaminophen administration, and this will be correlated to gastric emptying over the same period of time by the acetaminophen absorption test PK parameter, AUC60 mcg\*min/mL. As such, each patient will act as their own control. Correlation analysis will be applied to examine the performance of CSA measurements overtime using gastric ultrasound to determine gastric emptying compared to the acetaminophen absorption test as the gold standard.
Inter-rater reliability 1 year Measured using the following quantitative and qualitative ultrasound assessments between a novice and an expert gastric ultrasound operator:
* Qualitative using the previously published Perlas' US qualitative grading assessment
* Grade 0- no contents visualized in supine and lateral position
* Grade 1- contents visualized in the lateral decubitus position (RLD) only
* Grade 2- contents visualized in the supine and RLD.
* Quantitative assessment using the cross-sectional area as published by Spencer AO et al.
* Measurement of the CSA: longitudinal diameter (D1), and the antero-posterior diameter (D2) in both supine and RLD. Then these will be used to calculate the cross-sectional area (CSA) = (π\*D1\*D2)/4.
* Quantitative assessment using the cross-sectional area as published by Spencer AO et al.
* Measurement of the CSA: longitudinal diameter (D1), and the antero-posterior diameter (D2) in both supine and RLD. Then these will be used to calculate the cross-sectional area (CSA)
- Secondary Outcome Measures
Name Time Method Post-anesthetic outcomes 1 year Fasting times have been correlated to post-anesthetic outcomes such as post-operative nausea/ vomiting, and discomfort, and it is known that some patients fast longer than required by their clinical team, which can result in adverse effects. Reported fasting times for all patients and confirmatory assessment by gastric US will be examined along with data pulled from the medical record about post-operative nausea/ vomiting, post-operative discomfort, satisfaction, and whether the patient met their expected post-operative trajectory or not (e.g. unplanned admission).
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States