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Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Completed

Conditions

Gastric Ultrasound
Glucagon-like Peptide 1
Point of Care Ultrasound

Treatments

Other: Gastric Ultrasound Exam

Study type

Observational

Funder types

Other

Identifiers

NCT06003985
2023-0867

Details and patient eligibility

About

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.

Full 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.

Enrollment

354 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

354 participants in 2 patient groups

Control
Description:
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.
Treatment:
Other: Gastric Ultrasound Exam
GLP-1 agonist intake
Description:
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.
Treatment:
Other: Gastric Ultrasound Exam

Trial contacts and locations

8

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Central trial contact

Pa Thor, PhD; Maya Tailor

Data sourced from clinicaltrials.gov

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