Gastric Ultrasound for Obesity

DC
ML
Overseen ByMalikah Latmore, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the use of ultrasound imaging to view the stomachs of patients undergoing weight-loss surgery. Researchers will take images before and after the surgery while the patient is under anesthesia, ensuring no discomfort. The main goal is to understand the stomach's appearance using this imaging method, known as Gastric Point of Care Ultrasound. Individuals scheduled for bariatric surgery who have not had previous abdominal surgery might be suitable candidates for this study. As an unphased trial, it offers participants the opportunity to contribute to the advancement of medical imaging techniques for future surgical procedures.

Do I need to stop my current medications for this trial?

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 gastric point of care ultrasound is safe for imaging post-bariatric surgery?

Research has shown that gastric point-of-care ultrasound (POCUS) is generally safe for patients. Studies have used it to assess the risk of inhaling stomach contents into the lungs during surgery. This technique proves particularly useful for patients who may not have fasted properly. The procedure is usually well-tolerated, with minimal risks. The main concern is discomfort, but this will not be an issue here because patients will be under general anesthesia during the imaging. Overall, POCUS is considered a low-risk method for examining the stomach during weight-loss surgery.12345

Why are researchers excited about this trial?

Researchers are excited about using Gastric Point of Care Ultrasound (POCUS) for obesity because it offers a non-invasive way to assess stomach contents before bariatric surgery. Unlike traditional imaging techniques like CT scans or MRIs, which can be time-consuming and require specialized settings, POCUS is quick and can be performed bedside, making it highly convenient. Additionally, it doesn't involve radiation, which is safer for patients. This method could streamline pre-surgical evaluations, potentially improving the efficiency and safety of obesity treatments.

What evidence suggests that gastric point-of-care ultrasound is effective for imaging the stomachs of patients after bariatric surgery?

Research has shown that a quick ultrasound scan of the stomach, known as gastric point-of-care ultrasound (POCUS), can help assess stomach contents before surgery. In one study, 80% of patients had empty stomachs, allowing surgery to proceed without issues. Another study found that POCUS helped determine if surgery should be delayed, leading to changes in the treatment plan for 71% of patients. In this trial, participants in the Gastric Point of Care Ultrasound (POCUS) group will undergo this imaging method, which is particularly useful for assessing the risk of food or liquid entering the lungs in patients who may not have fasted properly before surgery. This imaging method provides a fast and non-invasive way to enhance surgical safety.12367

Who Is on the Research Team?

ML

Malikah Latmore, MD

Principal Investigator

Mount Sinai Morningside Hospital

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing bariatric surgery to address obesity and weight loss. The study involves patients having their stomachs imaged before and after the surgery while they are under general anesthesia.

Inclusion Criteria

I am scheduled for weight loss surgery.
I have never had surgery in my abdomen.
I am between 18 and 85 years old.

Exclusion Criteria

ASA physical status > 3
I have had surgery in my abdomen before.
I am unable or unwilling to give consent for treatment.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Pre-operative Imaging

Participants undergo gastric POCUS imaging after intubation and before the surgical team prepares a sterile field

Day of surgery
1 visit (in-person)

Post-operative Imaging

Participants undergo gastric POCUS imaging before extubation after the surgical procedure is complete

Day of surgery
1 visit (in-person)

Follow-up

Participants are monitored for postoperative aspiration events until hospital discharge

1-3 days

What Are the Treatments Tested in This Trial?

Interventions

  • Gastric Point of Care Ultrasound

Trial Overview

The study is testing the use of Gastric Point of Care Ultrasound (POCUS) to image patients' stomachs during bariatric procedures. Imaging will be done post-intubation pre-operatively, and pre-extubation post-operatively in a nonrandomized prospective setup.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Gastric Point of Care Ultrasound (POCUS) groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

Role of Point-of-Care Gastric Ultrasound in Advancing ...

Management changes occurred in 71% of patients in both directions; some patients who were initially delayed proceeded on time, while patients ...

Using Point-of-Care-Ultrasound (POCUS) to Assess ...

The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre- ...

Point-of-care gastric ultrasound: Redefining aspiration risk ...

Point-of-care gastric ultrasound is a key tool to assess perioperative aspiration risk especially in patients with risk factors (uncertain fasting, ...

Role of Gastric Point-of-Care Ultrasound in Perioperative ...

Twenty patients (80%) demonstrated empty stomachs on ultrasound and proceeded with surgery without complications. Gastric contents were found ...

5.

associationofanaesthetists-publications.onlinelibrary.wiley.com

associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.16472

Gastric ultrasound performance time and difficulty: a ...

Approximately 50 scans are required to achieve a baseline performance of 5 min per gastric ultrasound. Future training programmes should focus on patients with ...

Gastric Ultrasound in Patients Who Have Undergone Bariatric ...

There are minimal risks to gastric POCUS. Risks typically include discomfort to the patient, which will be avoided as the patient will be under ...

Feasibility and Utility of Routine Point‐of‐Care Gastric ...

Qualitative ultrasound measurements consistently determined safe and unsafe gastric residual contents in 83 patients enrolled in the study.