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?

This trial aims to determine if individuals new to using ultrasound (an imaging technique that uses sound waves) can be trained to assess stomach contents as effectively as experts. The focus is on using ultrasound to evaluate the risk of aspiration (inhaling stomach contents) during surgery. The trial consists of two parts: one involving healthy adults and the other involving children preparing for surgery. It seeks healthy adults over 18 and children with parental consent who are undergoing surgery under general anesthesia. As an unphased trial, it offers participants the chance to contribute to important research that could enhance surgical safety techniques.

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.

What prior data suggests that this ultrasonography technique is safe for evaluating gastric contents?

Research has shown that ultrasound, which uses sound waves to create images, is safe for children. Studies indicate it effectively confirms conditions like acid reflux when present. Importantly, ultrasound does not use radiation, enhancing its safety for children.

Ultrasound is generally easy to manage and painless. In some studies, experts used it to check stomach contents without any reported side effects. This suggests the procedure is safe and poses little risk to both adults and children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasonography for assessing gastric reflux in pediatric patients because it offers a non-invasive and radiation-free alternative to traditional methods like X-rays or endoscopy. Unlike these standard methods, ultrasonography allows for quick and real-time visualization of gastric contents without the need for sedation or exposure to radiation, making it safer and more comfortable, especially for children. Additionally, the educational component of training novice ultrasonographers to perform this assessment could potentially expand access to this diagnostic technique, helping more healthcare providers to evaluate gastric reflux safely and efficiently.

What evidence suggests that ultrasonography is effective for evaluating gastric reflux in pediatric patients?

Research has shown that ultrasound can reliably diagnose acid reflux in children. One study found ultrasound to be 100% accurate in identifying children with the condition, though it was less effective at detecting all cases. Another study found that infants with reflux had shorter esophageal sections in their abdomen compared to those without reflux. This trial will involve novice ultrasonographers assessing gastric contents in pediatric patients to evaluate ultrasound's effectiveness in predicting the risk of inhaling food or liquid into the lungs. These findings support using ultrasound to check stomach contents and predict aspiration risk in children. ^{1 2 3 6 7}

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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7925781/

Gastroesophageal and gastric ultrasound in children

The evaluation of children with gastroesophageal reflux disease requires an accurate ultrasonographic approach, but ultrasound requires more and accurate ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3099082/

Sonographic Measurement of Abdominal Esophageal ...

Results: Neonates and infants with reflux had a significantly shorter abdominal esophagus than subjects without reflux: the mean difference in neonates, 4.65 mm ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0146000525001387

The diagnosis of gastroesophageal reflux in the Neonate

The specificity and positive predictive value of ultrasound was 100 %, though with a low sensitivity of 38 %. Conversely, postprandial color ...

4.

researchgate.net

researchgate.net/publication/228653561_Children_gastroesophageal_reflux_and_ultrasound

(PDF) Children, gastroesophageal reflux and ultrasound

A few studies have excluded ultrasound as a reliable diagnostic tool in screening for gastroesophageal reflux disease (GERD) in infant and children.

5.

ajronline.org

ajronline.org/doi/10.2214/ajr.183.3.1830801

A Diagnostic Tool for Gastroesophageal Reflux | AJR

RESULTS. Neonates and infants with reflux had a significantly shorter abdominal esophagus than subjects without reflux: the mean difference in neonates, 4.8 mm; ...

6.

wjgnet.com

wjgnet.com/1948-5190/full/v15/i3/84.htm

Gastroesophageal reflux disease in children: What's new ...

Ultrasound has high sensitivity and positive predictive value for GERD as it can assess both the anatomy of the esophagus and real-time reflux.

7.

naspghan.org

naspghan.org/files/Pediatric_Gastroesophageal_Reflux_Clinical.33.pdf

Pediatric Gastroesophageal Reflux Clinical Practice

Finally 8 outcome measures were selected: esophagitis. (endoscopic/histologic), complications of GERD (Barrett metapla- sia, esophageal stenosis, and others as ...