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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06038734
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: gastric ultrasound

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Retained gastric contents [At time of pre-operative assessment]

    Presence of retained gastric contents, either liquid or solid

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina Medical Center Chapel Hill North Carolina United States 27514

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT06038734
Other Study ID Numbers:
  • 23-0578
First Posted:
Sep 15, 2023
Last Update Posted:
Sep 15, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2023