Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003985
Collaborator
(none)
314
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Gastric Ultrasound Exam

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
314 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Preoperative Gastric Content With Ultrasound in Patients Taking GLP1 Agonists
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Control

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.

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.

GLP-1 agonist intake

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Oliver Panzer, MD, Hospital for Special Surgery, Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT06003985
Other Study ID Numbers:
  • 2023-0867
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital for Special Surgery, New York

Study Results

No Results Posted as of Aug 22, 2023