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

NCT05889637 | Completed

• 1 other identifier: HSC-MS-23-0300
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Aspiration

Outcome Measures

Primary Outcomes (2)

• Number of subjects that are at risk for aspiration

  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

  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 Outcomes (10)

• Age

  end of ultrasound

• Number of participants that are male as indicated in the medical records

  end of ultrasound

• Number of participants that are female as indicated in the medical records

  end of ultrasound

• Body mass Index (BMI)

  end of ultrasound

• Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system

  end of ultrasound

Study Arms (2)

Group G: Patients taking GLP-1receptor agonists

Diagnostic Test: Gastric ultrasound

Group C: Patients not taking GLP-1 receptor agonists (control group)

Diagnostic Test: Gastric ultrasound

Interventions

Gastric ultrasound DIAGNOSTIC_TEST

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); Group G: Patients taking GLP-1receptor agonists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Sudipta Sen, MD,FASA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 5, 2023
• Study Start: June 6, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)