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

Completed

• Conditions: Pulmonary Aspiration
• Interventions: Diagnostic Test: Gastric ultrasound

• Registration Number: NCT05889637
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-05
• Study Start: 2023-06-06
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group G: Patients taking GLP-1receptor agonists	Gastric ultrasound	-
Group C: Patients not taking GLP-1 receptor agonists (control group)	Gastric ultrasound	-

Primary Outcome Measures

Name	Time	Method
Number of subjects that are at risk for aspiration	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
Number of subjects that are at low risk for aspiration	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.

Secondary Outcome Measures

Name	Time	Method
Age	end of ultrasound
Number of participants with Gastroesophageal reflux disease (GERD)	end of ultrasound
Body mass Index (BMI)	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.
Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system	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)
Number of participants with reported nothing by mouth (NPO) status	end of ultrasound
Number of participants that have use opioids preoperatively	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
Number of participants with diabetes	end of ultrasound
Pain severity as assessed by the numeric scale	end of ultrasound	This is a 11 point scale with scores ranging from 0 (no pain) to 10 (worst imaginable pain)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States