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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT05889637

Collaborator

(none)

124

Enrollment

Location

11.8

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Aspiration	Diagnostic Test: Gastric ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

124 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 6, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

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

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]
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 diabetes [end of ultrasound]
Number of participants with reported nothing by mouth (NPO) status [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)
Number of participants with Gastroesophageal reflux disease (GERD) [end of ultrasound]
Number of participants that have use opioids preoperatively [end of ultrasound]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sudipta Sen, Assisstant Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT05889637

Other Study ID Numbers:

HSC-MS-23-0300

First Posted:

Jun 5, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 8, 2023