Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists

August 1, 2023 updated by: Sudipta Sen, The University of Texas Health Science Center, Houston

Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1(GLP-1) Receptor Agonists

The purpose of this study is to determine the type of gastric content and quantify the volume of liquid gastric contents using ultrasonography in patients on GLP-1 agonists that have presented for elective surgery and to determine if risk factors are associated with a higher gastric volume in patients on GLP-1 receptor agonists.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

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

No

Sampling Method

Non-Probability Sample

Study Population

subjects presenting for elective surgery who are on Glucagon-Like peptide-1 agonist subcutaneous injection, once weekly will be included

Description

Inclusion Criteria:

  • Patients taking GLP-1receptor agonists (N=62)
  • Patients not taking GLP-1 receptor agonists (N=62)

Exclusion Criteria:

  • Previous gastric resection or bypass
  • Gastric band in situ
  • Previous fundoplication
  • Large hiatal hernia
  • Pregnant patients
  • Recent trauma
  • Inability to turn to the right lateral decubitus position

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
Group G: Patients taking GLP-1receptor agonists
Diagnostic test: Gastric ultrasound
Patient will be scanned first in the supine position and then in the right lateral decubitus position. The ultrasound probe will be placed in a sagittal plane in the epigastric region at the left subcostal margin and then will be moved past the midline in a fan like manner to the right subcostal region. Qualitative and quantitative assessments will be done.
Group C: Patients not taking GLP-1 receptor agonists (control group)
Diagnostic test: Gastric ultrasound
Patient will be scanned first in the supine position and then in the right lateral decubitus position. The ultrasound probe will be placed in a sagittal plane in the epigastric region at the left subcostal margin and then will be moved past the midline in a fan like manner to the right subcostal region. Qualitative and quantitative assessments will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects that are at risk for aspiration
Time Frame: end of ultrasound
Risk for aspiration is indicated by the presence of solids, thick fluid, or clear fluids >1.5ml/kg in the gastric antrum in the right lateral decubitus position
end of ultrasound
Number of subjects that are at low risk for aspiration
Time Frame: end of ultrasound
Low risk for aspiration is indicated by a collapsed gastric antrum or clear fluids <1.5ml/kg in the gastric antrum in the right lateral decubitus position.
end of ultrasound

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: end of ultrasound
end of ultrasound
Number of participants that are male as indicated in the medical records
Time Frame: end of ultrasound
end of ultrasound
Number of participants that are female as indicated in the medical records
Time Frame: end of ultrasound
end of ultrasound
Body mass Index (BMI)
Time Frame: end of ultrasound
Body Mass Index (BMI) is calculated as the body mass in kilograms (kg) divided by the square of the body height in meters, and is expressed in units of kg/m2.
end of ultrasound
Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system
Time Frame: end of ultrasound
The classification ranges from American Society of Anesthesiologists (ASA)1 (normal healthy person ) to ASA IV (A patient with severe systemic disease that is a constant threat to life)
end of ultrasound
Number of participants with diabetes
Time Frame: end of ultrasound
end of ultrasound
Number of participants with reported nothing by mouth (NPO) status
Time Frame: end of ultrasound
end of ultrasound
Pain severity as assessed by the numeric scale
Time Frame: end of ultrasound
This is a 11 point scale with scores ranging from 0 (no pain) to 10 (worst imaginable pain)
end of ultrasound
Number of participants with Gastroesophageal reflux disease (GERD)
Time Frame: end of ultrasound
end of ultrasound
Number of participants that have use opioids preoperatively
Time Frame: end of ultrasound
end of ultrasound

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Sudipta Sen, MD,FASA, The University of Texas Health Science Center, Houston

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)

June 6, 2023

Primary Completion (Actual)

July 12, 2023

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HSC-MS-23-0300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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