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

December 4, 2023 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GLP-1 agonists
Pre-operative gastric ultrasound to evaluate for retained gastric contents in appropriately fasted patients
Diagnostic test: gastric ultrasound
Utilize POC gastric ultrasound to identify the presence of retained gastric contents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retained gastric contents
Time Frame: At time of pre-operative assessment
Presence of retained gastric contents, either liquid or solid
At time of pre-operative assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Lindsey Gouker, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

Beginning 9 and continuing for 36 months following publication

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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