Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists

Point of Care Ultrasound Clinical Trial

Official title:

Assessment of Preoperative Gastric Content With Ultrasound in Patients Taking GLP1 Agonists

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003985
• Other study ID #: 2023-0867
• Status: Recruiting
• Start date: August 29, 2023
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: Justas Lauzadis, PhD
• Phone: 212-774-2946
• Email: lauzadisj[@]hss.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who take glucagon-like peptide 1 (GLP-1) agonist medications compared to patients who do not take GLP-1 agonists.

Description:

Glucagon-like peptide 1 (GLP-1) agonists have existed since 2005, however the newer once-weekly injectable medications particularly semaglutide, and tirzepatide have exploded in popularity due to their weight loss potential.

Anesthesiologists nationally have seen an increase in perioperative complications amongst patients taking these medications due to delayed gastric emptying increasing the risk of aspiration in the perioperative period. At HSS the majority of our anesthetics are done under sedation and therefore would not protect the patient from aspiration in the event of vomiting.

Protecting patients from aspiration secondary to vomiting during induction or maintenance of anesthesia has always been an important goal to make anesthesia safer leading to the development of NPO guidelines which are intended to protect against the presence of gastric content during anesthetic care. However there is growing concern that patients taking GLP-1 agonists may not be adequately protected using the current nothing by mouth or "NPO" guidelines. Up to this day there is no literature on how much gastric emptying is delayed during the use of GLP1 following the standard NPO guidelines.

Recently Gastric Ultrasound (GUS) has been introduced as a bedside tool for assessing a patients stomach contents and for the risk of aspiration. Gastric ultrasound can identify an empty stomach, a stomach filled with clear liquids, thick liquids or solid food content. If a stomach has clear liquid the volume can be calculated accurately. Generally a stomach with solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight is considered a full stomach. As GUS is noninvasive and well tolerated, it offers the perfect solution to assessing patient risk in the preoperative period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• GLP 1 patient group: any patient on GLP1 agonists that are dosed once per week (semaglutide, dulaglutide, tirzepatide), for all indications.

• Control group (No GLP 1 patients): any patient not on GLP1 agonists that are dosed once per week, for all indications.

Exclusion Criteria:

• patient refusal to participate

• patients with gastric bypass or any other gastric surgery

• large hiatal hernia

• patients with large ascites

• patients on peritoneal dialysis

• emergency surgery

• pre-existing diagnosis of gastroparesis

Related Conditions & MeSH terms

• Gastric Ultrasound
• Glucagon-like Peptide 1
• Point of Care Ultrasound

Intervention

Other:
• Gastric Ultrasound Exam
A gastric ultrasound is a simple, fast, non-invasive bedside diagnostic test that provides a qualitative and quantitative assessment of gastric contents. There are no known risks of a gastric ultrasound exam.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
United States	Albany Medical Center	Albany	New York
United States	Mayo Clinic	Jacksonville	Florida
United States	Hospital for Special Surgery	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Maselli DB, Camilleri M. Effects of GLP-1 and Its Analogs on Gastric Physiology in Diabetes Mellitus and Obesity. Adv Exp Med Biol. 2021;1307:171-192. doi: 10.1007/5584_2020_496. — View Citation

Nakatani Y, Maeda M, Matsumura M, Shimizu R, Banba N, Aso Y, Yasu T, Harasawa H. Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy. Diabetes Metab. 2017 Oct;43(5):430-437. doi: 10.1016/j.diabet.2017.05.009. Epub 2017 Jun 23. — View Citation

Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delayed gastric emptying	delayed gastric emptying is defined by the presence of either solid food, thick liquids or a specific volume (>1.5 ml/kg) of clear liquids on gastric ultrasound.	This will be measured pre-operatively in the holding room area.
Secondary	Nothing by mouth (NPO) intervals	Measure the NPO interval after last solid, liquids, and clears precisely for a subgroup analysis.	This will be measured pre-operatively in the holding room area.
Secondary	Presence of gastric peristalsis	Gastric peristalsis will be graded as present/ absent on gastric ultrasound	This will be measured pre-operatively in the holding room area.