Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists
- Conditions
- Glucagon-like Peptide 1Point of Care UltrasoundGastric Ultrasound
- Interventions
- Other: Gastric Ultrasound Exam
- Registration Number
- NCT06003985
- Lead Sponsor
- Hospital for Special Surgery, New York
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GLP-1 agonist intake Gastric Ultrasound Exam The GLP-1 agonist intake group will be comprised of patients who are currently taking any GLP-1 agonist medications. This group will receive the ultrasound exam to assess stomach contents. Control Gastric Ultrasound Exam The control group will be comprised of patients who are not currently taking any GLP-1 agonist medications. Controls will receive the ultrasound exam to assess stomach contents.
- Primary Outcome Measures
Name Time Method incidence of delayed gastric emptying This will be measured pre-operatively in the holding room area. 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.
- Secondary Outcome Measures
Name Time Method Presence of gastric peristalsis This will be measured pre-operatively in the holding room area. Gastric peristalsis will be graded as present/ absent on gastric ultrasound
Nothing by mouth (NPO) intervals This will be measured pre-operatively in the holding room area. Measure the NPO interval after last solid, liquids, and clears precisely for a subgroup analysis.
Trial Locations
- Locations (8)
George Washington University Hospital
🇺🇸Washington, D.C., District of Columbia, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University Health Network
🇨🇦Toronto, Ontario, Canada