Gastric Assessment of Pediatric Patients Undergoing Surgery

Fasting Clinical Trial

Official title:

Gastric Assessment of Pediatric Patients Undergoing Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674643
• Other study ID #: IRB-P00040829
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Boston Children's Hospital
• Contact: Jocelyn Booth, BSN
• Phone: 857-218-4585
• Email: jocelyn.booth[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Delayed Gastric Emptying
• Fasting
• Gastroparesis
• Pneumonia, Aspiration
• Respiratory Aspiration
• Respiratory Aspiration of Gastric Content
• Respiratory Aspiration of Gastric Contents

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-rater reliability	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) = (p*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)	1 year
Primary	Intra-rater reliability	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) = (p*D1*D2)/4.	1 year
Primary	Gastric Emptying	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.	1 year
Secondary	Post-anesthetic outcomes	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).	1 year