Gastric Ultrasound for Obesity

Overseen By Malikah Latmore, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: ASA status > 3, Urgent surgery, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care ultrasound (POCUS). The pre-operative imaging will be done post-intubation and the post-operative imaging will be done pre-extubation. There are minimal risks to gastric POCUS. Risks typically include discomfort to the patient, which will be avoided as the patient will be under general anesthesia at the time of imaging.

Who Is on the Research Team?

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.

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?

Group I: Gastric Point of Care Ultrasound (POCUS) group Experimental Treatment 1 Intervention

Participates scheduled to undergo bariatric surgery and have had no prior abdominal surgery.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+