Bedside Ultrasound of Gastric Contents in Pediatric Populations

NCT03520374 | Recruiting FDA Device

• 1 other identifier: 44959
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Contents

Keywords

ultrasound; gastric contents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time elapsed to reach gastric 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.

Study Arms (2)

Healthy adult volunteers

OTHER

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

Pediatric patients

OTHER

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

Interventions

Ultrasonography DIAGNOSTIC_TEST

Ultrasonography use for the evaluation of gastric contents

Healthy adult volunteers; Pediatric patients

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must:
• be between ages of 2-60 years of age
• 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
• undergoing interventional radiology procedures under general anesthesia or located at an inpatient/outpatient facility at LPCH if they are a pediatric patient
• must be over 18 years of age if a healthy volunteer

You may not qualify if:

• Patients undergoing emergent surgical procedures
• BMI greater than 24

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

LPCH/SHC

Stanford, California, 94305, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 29265187 RESULT

• 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.

  PMID: 27119308 RESULT

• 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.

  PMID: 24595113 RESULT

• 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.

  PMID: 29315130 RESULT

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ban CH Tsui, MD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Ban CH Tsui, MD

CONTACT

6504970927; bantsui@stanford.edu

Ksenia Kasimova, MD

CONTACT

6507889458; kasimova@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: August 2, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)