Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.

NCT06038734 | Completed

• 1 other identifier: 23-0578
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.

Conditions

Delayed Gastric Emptying; Gastroparesis

Keywords

GLP-1 agonists; retained gastric contents; glucagon-like peptide receptor-1 agonists; perioperative

Outcome Measures

Primary Outcomes (1)

• Retained gastric contents

  Presence of retained gastric contents, either liquid or solid

  At time of pre-operative assessment

Study Arms (2)

GLP-1 agonists

Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are using GLP-1 agonist medications.

Diagnostic Test: gastric ultrasound

Control

Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients who are not using GLP-1 agonist medications.

Diagnostic Test: gastric ultrasound

Interventions

gastric ultrasound DIAGNOSTIC_TEST

Utilize POC gastric ultrasound to identify the presence of retained gastric contents.

Control; GLP-1 agonists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include non-critically ill adults 18 years and older undergoing various elective surgical procedures at the University of North Carolina Medical Center

You may qualify if:

• GLP-1 agonist use within previous 30 days
• Appropriately fasted per standard guidelines

You may not qualify if:

• History of gastric surgery / gastric volume reduction
• Critical illness
• Inability to provide informed consent
• \<18 years of age

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lindsey Gouker, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: November 10, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: June 27, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)