Ultrasound for Surgery Preparation

Overseen By Julie Rice-Weimer

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Vidya Raman

Disqualifiers: Non-adherence to fasting guidelines

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an ultrasound, which uses sound waves to view the body's interior, can accurately measure the stomach's contents in children before and after they consume a small amount of premedication before surgery. The researchers expect the ultrasound to show that the stomach appears the same before and after, as the medicine occupies minimal space. Children scheduled for surgery who can fast (abstain from eating or drinking for a certain period) are suitable candidates for this trial. As an unphased study, this trial provides an opportunity to contribute to important research that could enhance surgical preparation for children.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this ultrasound technique is safe for surgery preparation?

Research has shown that using a stomach ultrasound before surgery is safe and non-invasive. Studies have found that this method accurately assesses the stomach's contents and size, aiding doctors in selecting the safest anesthesia approach. The procedure employs a handheld device to capture images of the stomach without harmful radiation or discomfort.

Participants generally tolerate the procedure well, and these studies have reported no major side effects. The ultrasound resembles those used in routine pregnancy check-ups, which many find easy and painless. This makes it a safe choice for verifying if children have fasted before surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using premedication gastric ultrasound as a surgery preparation tool because it offers a non-invasive way to assess a child's stomach contents before anesthesia. Unlike traditional methods that rely on fasting guidelines and physical exams, this ultrasound technique provides real-time visualization, potentially improving safety by reducing the risk of aspiration during surgery. Additionally, the ability to quickly and accurately evaluate gastric content can lead to more personalized and efficient surgical care.

What evidence suggests that this ultrasound method is effective for assessing gastric volume in fasted children?

Research has shown that gastric ultrasound effectively checks the amount of food or liquid in the stomach. Studies have found it accurately determines if the stomach is empty, which is crucial before surgery to reduce the risk of aspiration. In this trial, fasted children will undergo gastric ultrasound to confirm their stomachs are empty, even after taking pre-surgery medication, which typically doesn't significantly fill the stomach. Overall, this tool is reliable for ensuring patient safety before surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for fasted children who are scheduled to undergo surgery. The study aims to include those who have not consumed food or drink for a certain period before the procedure, as per standard pre-surgical fasting guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Ultrasound assessment of gastric volume in fasted children before and after drinking premedication

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Premedication Gastric Ultrasound

Trial Overview The trial is testing the use of point-of-care ultrasound to assess gastric volume in children before and after they consume a small amount of premedication liquid. It's designed to see if the medication affects stomach fullness.

How Is the Trial Designed?

Group I: Fasted Children Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vidya Raman

Lead Sponsor

Trials

10

Recruited

1,002,000+

Kevin Spellman

Lead Sponsor

Ajay D'Mello

Lead Sponsor

Trials

1

Recruited

100+

Alok Moharir

Lead Sponsor

Trials

3

Recruited

250+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41032460/

Assessment of Gastric Content Using Gastric Ultrasound in ... The primary outcome was high RGC, defined by the presence of solids food or >1.5 mL/kg of clear liquids on GUS, and its association with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10833037/

Preoperative gastric point-of-care ultrasound in nonelective ... The preliminary data show that when patients presenting for nonelective surgery are appropriately NPO, they may have a low risk of aspiration.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04181814

Study Details | NCT04181814 | Gastric Ultrasound for ... This prospective observational study aim to explore the gastric emptying of type 2 diabetic patients. Detailed Description. ASA fasting guidelines are only ...

4. mdpi.com mdpi.com/2077-0383/14/2/641

Ultrasound Evaluation of Gastric Emptying and ... This study demonstrated that USG is an effective and accurate tool for assessing residual gastric content in patients adhering to preoperative fasting ...

5. theultrasoundjournal.springeropen.com theultrasoundjournal.springeropen.com/articles/10.1186/s13089-023-00307-8

Assessment of residual gastric volume using point-of-care ... We conducted an observational study to determine the gastric residual volume in preoperative patients of elective surgery with gastric ultrasound.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39663603/

Enhancing preoperative risk assessment and patient safety Gastric ultrasound (GUS) provides a non-invasive, reliable method for assessing gastric content and volume, enabling anaesthesia professionals to make informed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6190418/

Preoperative assessment of gastric contents and volume ... The aim of this study was to determine, with the help of ultrasound, the gastric volume and content in fasted patients presenting for elective surgeries.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2210844021000599

Preoperative Gastric Ultrasound in Surgical Patients who ... A preoperative evaluation of aspiration risk is essential for safe airway management. Pulmonary aspiration is associated with high morbidity and mortality and ...

9. bjaed.org bjaed.org/article/S2058-5349(19)30047-2/fulltext

Perioperative point-of-care gastric ultrasound Gastric ultrasound is used when prandial status is uncertain or gastric emptying might be delayed. Images are acquired with a curvilinear transducer in the ...

10. mdpi.com mdpi.com/2075-4418/14/21/2366

Role of Point-of-Care Gastric Ultrasound in Advancing ... Gastric ultrasound can be utilized in the preoperative setting for risk assessment and in shared decision making with the patient regarding the ...