Effects of GLP-1 Agonists on Gastric Volume

Study Overview
=================
Brief Summary
-----------------
This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.

Official Title
-----------------
Ultrasound Assessment of Preoperative Gastric Volume in Fasted, Diabetic Surgical Patients: A Prospective Observational Cohort Study on the Effects of GLP-1 Agonists on Gastric Emptying

Conditions
-----------------
Diabetes, Gastric Content Aspiration, Glucagon-like Peptide 1, GLP-1

Intervention / Treatment
-----------------
* Diagnostic Test: Gastric Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age greater than or equal to 18 years old Diagnosed with diabetes (listed on medical record, Hgb A1C greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dL, and/or on medical treatment for diabetes) One of the following groups: Taking a GLP-1 Medication Not taking a GLP-1 Medication ASA Physical Classification Status 1-3 Scheduled for elective surgery under general anesthesia Appropriately fasted per ASA Fasting Guidelines 201712 Exclusion Criteria BMI greater than 40 Previous gastric/esophageal surgery Abnormal gastric anatomy Pregnancy Inability or unwillingness of subject to give informed consent Non-English Speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetics taking a GLP-1 receptor agonist<br> | Diagnostic Test: Gastric Ultrasound<br>* A gastric ultrasound will be completed on every patient and administered the same way in each arm. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position and the above procedure will be repeated.<br>|
| Diabetics not taking a GLP-1 receptor agonist (control)<br> | Diagnostic Test: Gastric Ultrasound<br>* A gastric ultrasound will be completed on every patient and administered the same way in each arm. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position and the above procedure will be repeated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Volume in RLD Position | The gastric volume will be calculated using a validated formula. | From time of enrollment until the start of surgery, assessed up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric antrum CSA in RLD position |  | From time of enrollment until the start of surgery, assessed up to 4 weeks | 
| Perlas antral grade |  | From time of enrollment until the start of surgery, assessed up to 4 weeks | 
| Incidence of aspiration |  | From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours |