Recruiting

Ultrasound

Sponsor:

Stanford University

Code:

NCT03520374

Conditions

Gastric Contents

Eligibility Criteria

Sex: All

Age: 2 - 60

Healthy Volunteers: Accepted

Interventions

Ultrasonography

Study Details

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

Study ID

NCT03520374

Start date

Aug 2, 2018

Status verified date

Apr, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Ultrasonography

Ultrasonography use for the evaluation of gastric contents

Primary outcome measure

  • Novice vs Expert Ultrasonographers Gastric Evaluation [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Ban CH Tsui, MD

6504970927bantsui@stanford.edu

Ksenia Kasimova, MD

6507889458kasimova@stanford.edu

Locations

LPCH/SHC

Recruiting

Stanford, California, United States, 94305

More Information

Sponsor

Stanford University

Last update posted

May 1, 2025

Last verified

Apr, 2025

Keywords

  • ultrasound
  • gastric contents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-01.