Bedside Ultrasound of Gastric Contents in Pediatric Populations

Evaluating the Effectiveness of a Self-instructional Ultrasound Training Program at Teaching Aspiration Risk Assessment Through Gastric Ultrasound

Perioperative aspiration of gastric contents is a rare but serious adverse event. The risk of aspiration can be estimated by perioperative evaluation of stomach contents with ultrasound using a validated technique and scoring system. A lack of knowledge or familiarity is frequently cited by anesthesia providers as a rationale for not performing perioperative ultrasound assessments. The purpose of this study is to determine whether novice ultrasonography users (medical students, undergraduates, or inexperienced anesthesiologists) can be effectively taught a technique to evaluate stomach contents as compared to experts in ultrasonography.

Study Overview

• Status: Recruiting
• Conditions: Gastric Contents
• Intervention / Treatment: Diagnostic test: Ultrasonography

Detailed Description

This study will be conducted in two arms. For part 1, we will evaluate the efficacy of the self-taught course at producing accurate reads among novice ultrasound users on ideal, cooperative, adult subjects. For part 2, we will evaluate the effectiveness of the course through an identical study that uses clinical pediatric patients as subjects.

Using available literature and established standards for gastric ultrasound, a 15-minute ultrasound training video course will be designed that gives instruction on ultrasound orientation, use, and the antral scoring system of gastric contents. Ten novice ultrasound users will be selected by study personnel on a volunteer basis from a pool of undergraduate students, medical students, and inexperienced anesthesiologists acting as research interns.

For Part 1, 30 healthy adult volunteers with unknown gastric-content status will be recruited to serve as scanning subjects. For Part 2 (which will only begin after successful completion of Part 1), 30 patients will be recruited from pediatric hospital populations undergoing surgery in the preoperative area or the in- patient unit.

Each novice will assess the gastric contents of 6 subjects (3 in Part 1 and 3 in Part 2) using the clinical algorithm for gastric ultrasound and aspiration risk assessment - giving an antral grade for each subject (a score of 0-2). Each novice ultrasound assessment will be video recorded. In the weeks following this evaluation, expert ultrasonographers will observe each video and give their own scores for each subject using the antral grading system.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ban CH Tsui, MD; Phone Number: 6504970927; Email: bantsui@stanford.edu
• Study Contact Backup: Name: Ksenia Kasimova, MD; Phone Number: 6507889458; Email: kasimova@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • LPCH/SHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients must:

1. be between ages of 2-60 years of age
2. have parental consent for children 2-17 years of age, or if the participant is 18 years or older, the participant must sign the ICF for them self as an adult
3. undergoing interventional radiology procedures under general anesthesia or located at an inpatient/outpatient facility at LPCH if they are a pediatric patient
4. must be over 18 years of age if a healthy volunteer

Exclusion Criteria:

1. Patients undergoing emergent surgical procedures
2. BMI greater than 24

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy adult volunteers; Novice ultrasonographers will be taught to assess gastric contents with a short and simple educational program. Each novice will assess the gastric contents of 3 healthy adult volunteers using the clinical algorithm for gastric ultrasound and aspiration risk assessment - giving an antral grade for each subject (a score of 0-2). Each novice ultrasound assessment will be video recorded. In the weeks following this evaluation, expert ultrasonographers will observe each video and give their own scores for each subject using the antral grading system.	Diagnostic test: Ultrasonography; Ultrasonography use for the evaluation of gastric contents
Other: Pediatric patients; Novice ultrasonographers will be taught to assess gastric contents with a short and simple educational program. Each novice will assess the gastric contents of 3 pediatric patients undergoing surgery in the preoperative area or the in-patient unit using the clinical algorithm for gastric ultrasound and aspiration risk assessment - giving an antral grade for each subject (a score of 0-2). Each novice ultrasound assessment will be video recorded. In the weeks following this evaluation, expert ultrasonographers will observe each video and give their own scores for each subject using the antral grading system.	Diagnostic test: Ultrasonography; Ultrasonography use for the evaluation of gastric contents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Novice vs Expert Ultrasonographers Gastric Evaluation	The gastric evaluation of novice and expert ultrasonographers will be compared based on a 3-point numerical evaluation.	Novice ultrasonographers: for pediatric patients - after anesthesia induction and before the procedure start, for healthy volunteers - hours following signing the consent form. Expert ultrasonographers: weeks following the initial evaluation by novices.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time elapsed to reach gastric evaluation	Time elapsed to reach gastric evaluation will be assessed in both novice and expert ultrasonographers	Novice ultrasonographers: for pediatric patients - after anesthesia induction and before the procedure start, for healthy volunteers - hours following signing the consent form. Expert ultrasonographers: weeks following the initial evaluation by novices.

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Ban CH Tsui, MD, Stanford University

Publications and helpful links

General Publications

• Arzola C, Perlas A, Siddiqui NT, Downey K, Ye XY, Carvalho JCA. Gastric ultrasound in the third trimester of pregnancy: a randomised controlled trial to develop a predictive model of volume assessment. Anaesthesia. 2018 Mar;73(3):295-303. doi: 10.1111/anae.14131. Epub 2017 Dec 19.
• Spencer AO, Walker AM, Lardner DR, Perlas A. Reply to Schmitz et al. regarding 'Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes'. Paediatr Anaesth. 2016 Jun;26(6):672-3. doi: 10.1111/pan.12915. No abstract available.
• Kruisselbrink R, Arzola C, Endersby R, Tse C, Chan V, Perlas A. Intra- and interrater reliability of ultrasound assessment of gastric volume. Anesthesiology. 2014 Jul;121(1):46-51. doi: 10.1097/ALN.0000000000000193.
• Khurana J, Gartner SC, Naik L, Tsui BCH. Ultrasound Identification of Diaphragm by Novices Using ABCDE Technique. Reg Anesth Pain Med. 2018 Feb;43(2):161-165. doi: 10.1097/AAP.0000000000000718.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; gastric contents
• Other Study ID Numbers: 44959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be de-identified. Data will be used collectively for research analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No