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NCT Number: NCT03520374

Bedside Ultrasound of Gastric Contents in Pediatric Populations

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.

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Key information

Conditions

Age range

2 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LPCH/SHC

Stanford, California, 94305, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients undergoing emergent surgical procedures
  • BMI greater than 24

Treatment and study plan

ultrasonography

Diagnostic Test

Ultrasonography use for the evaluation of gastric contents

Primary outcomes

  1. 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.

    The gastric evaluation of novice and expert ultrasonographers will be compared based on a 3-point numerical evaluation.

Secondary outcomes

  1. Time elapsed to reach 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.

    Time elapsed to reach gastric evaluation will be assessed in both novice and expert ultrasonographers

Study contacts

Contact information is provided by the study sponsor or research team.

Ban CH Tsui, MD

CONTACT

[email protected]

6504970927

Ksenia Kasimova, MD

CONTACT

[email protected]

6507889458

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 9, 2018
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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