Ultrasonography for Gastric Reflux in Pediatric Populations

Overseen By Ksenia Kasimova, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Emergent surgery, BMI over 24

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is ultrasonography safe for use in children?

Ultrasonography (also known as ultrasound or sonography) is considered safe for use in children, as it is a non-invasive and innocuous test. Studies have shown it to be effective and safe for diagnosing conditions like gastroesophageal reflux in children. ^{1 2 3 4 5}

How does ultrasonography differ from other treatments for gastric reflux in children?

Ultrasonography (a type of imaging test) for gastric reflux in children is unique because it is non-invasive, does not involve radiation, and can provide dynamic images of the digestive tract, making it a safer and more comfortable option compared to traditional methods like pH monitoring or barium swallow tests. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Ultrasonography for Gastric Reflux in Pediatric Populations?

Research shows that ultrasonography (a type of imaging using sound waves) is effective in diagnosing gastroesophageal reflux in children, with high sensitivity and specificity. It is a non-invasive method that provides accurate results, making it a useful tool for screening and monitoring this condition. ^{1 2 6 9 10}

Who Is on the Research Team?

Ban CH Tsui, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals aged 2-60, including children with parental consent and adults who can consent for themselves. It's aimed at those undergoing general anesthesia or pediatric patients in certain facilities. Healthy volunteers over 18 can also join, but not if they have a BMI over 24.

Inclusion Criteria

Patients must be between ages of 2-60 years of age

Patients must be undergoing interventional radiology procedures under general anesthesia or located at an inpatient/outpatient facility at LPCH if they are a pediatric patient

Exclusion Criteria

Patients undergoing emergent surgical procedures

Patients with a BMI greater than 24

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training

Novice ultrasonographers are taught to assess gastric contents with a short and simple educational program

15 minutes

1 session (in-person)

Evaluation Part 1

Novice ultrasonographers assess gastric contents of healthy adult volunteers using the clinical algorithm for gastric ultrasound and aspiration risk assessment

1-2 weeks

3 assessments per novice

Evaluation Part 2

Novice ultrasonographers assess gastric contents of pediatric patients using the clinical algorithm for gastric ultrasound and aspiration risk assessment

1-2 weeks

3 assessments per novice

Expert Review

Expert ultrasonographers review video recordings of novice assessments and provide their own scores

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the training and evaluation phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasonography

Trial Overview The study tests whether people new to ultrasound (like medical students or inexperienced anesthesiologists) can learn to assess stomach contents before surgery as well as experts. This could help estimate the risk of aspiration during procedures.

How Is the Trial Designed?

Group I: Pediatric patients Experimental Treatment 1 Intervention

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.

Group II: Healthy adult volunteers Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a large retrospective analysis involving over 78,000 doses of ultrasound contrast agents (Definity and Optison), only 0.01% of patients experienced severe adverse reactions, indicating a strong safety profile for these agents.

The study found that severe reactions were primarily in outpatients, with no serious events reported in critically ill patients, suggesting that ultrasound contrast agents are safe for use in a variety of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. Wei, K., Mulvagh, SL., Carson, L., et al.[2022]

In a study involving 23,188 abdominal examinations using the ultrasound contrast agent SonoVue, only 29 adverse events (AEs) were reported, indicating a very low incidence of complications.

The overall rate of serious adverse events was extremely low at 0.0086%, and SonoVue demonstrated a good safety profile, comparable to or better than other contrast agents used in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Piscaglia, F., Bolondi, L.[2022]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Gastro-esophageal reflux: comparative study between sonography and pH monitoring. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

[The diagnosis of gastroesophageal reflux in childhood: a comparison between echography and pH measurement]. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Ultrasonographic study of postcibal gastro-esophageal reflux and gastric emptying in infants with recurrent respiratory disease. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

The role of sonography in the evaluation of gastro-oesophageal reflux--correlation to pH-metry. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnosis of gastro-oesophageal reflux in preterm infants: sonography vs. pH-monitoring. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Influence of contrast-enhanced ultrasound administration setups on microbubble enhancement: a focus on pediatric applications. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]

9. Romania pubmed.ncbi.nlm.nih.gov

A comparison between gastroesophagheal ultrasonography vs. barium swallow in determining the pattern of gastroesophageal reflux in a pediatric population. [2018]

10. Spain pubmed.ncbi.nlm.nih.gov

Intestinal ultrasound in pediatrics. [2021]