Gastric Ultrasound in Patients Who Have Undergone Bariatric Surgery

NCT07310875 | Not Yet Recruiting

• 1 other identifier: STUDY-23-01595
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Weight Loss; Gastrectomy

Keywords

Point of Care Ultrasound; Sleeve gastrectomy

Outcome Measures

Primary Outcomes (2)

• Change in distance from peritoneal wall

  Range: 3-5 cm. Higher score indicates greater displacement and less utility of gastric point-of-care ultrasound in these patients.

  end of the individual's procedure, at 2 hrs after procedure start on postoperative day 0

• Gastric antrum Cross-sectional area (CSA)

  Range: 1-10 centimeters squared. Gastric antrum Cross-sectional area (CSA) is a calculated product of Anteroposterior (AP) Diameter and Craniocaudal (CC) diameter. (CSA = AP x CC) Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.

  end of the individual's procedure, at 2 hrs after procedure start

Secondary Outcomes (3)

• Anteroposterior (AP) Diameter

  end of the individual's procedure, at 2 hrs after procedure start

• Craniocaudal (CC) diameter

  end of the individual's procedure, at 2 hrs after procedure start

• Postoperative aspiration events

  until day of hospital discharge, average 1-3 days

Study Arms (1)

Gastric Point of Care Ultrasound (POCUS) group

EXPERIMENTAL

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

Procedure: Gastric Point of Care Ultrasound

Interventions

Gastric Point of Care Ultrasound PROCEDURE

After the patient has undergone intubation, the patient will be positioned in the supine and then the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient below the xiphoid process. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. After the images are obtained, the patient will be repositioned to supine for the procedure. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS prior to extubation.

Gastric Point of Care Ultrasound (POCUS) group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• scheduled to undergo bariatric surgery
• no prior abdominal surgery

You may not qualify if:

• ASA physical status \> 3
• Urgent or emergent surgery
• Patient refusal or inability to consent
• Prior abdominal surgery

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West and Morningside

New York, New York, 10025, United States

Location

Related Publications (3)

• Pai SL, Bojaxhi E, Logvinov II, Porter SB, Feinglass NG, Robards CB, Torp KD. Ultrasound Assessment of Gastric Volume After Bariatric Surgery: A Case Report. A A Pract. 2019 Jan 1;12(1):1-4. doi: 10.1213/XAA.0000000000000824.

  PMID: 29985844 BACKGROUND

• Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6.

  PMID: 12768174 BACKGROUND

• Gulak MA, Murphy P. Regurgitation under anesthesia in a fasted patient prescribed semaglutide for weight loss: a case report. Can J Anaesth. 2023 Aug;70(8):1397-1400. doi: 10.1007/s12630-023-02521-3. Epub 2023 Jun 6.

  PMID: 37280458 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Malikah Latmore, MD

  Mount Sinai Morningside Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane C Armenta, MD, MS

CONTACT

845-260-0573; Diane.Armenta@mountsinai.org

Malikah Latmore, MD

CONTACT

917-364-3377; Malikah.Latmore@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regional Anesthesia and Acute Pain Medicine Fellowship Director

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to Malikah.Latmore@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).

Locations

US (1)