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

Pulmonary Aspiration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05889637
• Other study ID #: HSC-MS-23-0300
• Status: Completed
• Start date: June 6, 2023
• Est. completion date: July 12, 2023

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Aspiration

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Age		end of ultrasound
Secondary	Number of participants that are male as indicated in the medical records		end of ultrasound
Secondary	Number of participants that are female as indicated in the medical records		end of ultrasound
Secondary	Body mass Index (BMI)	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
Secondary	Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system	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
Secondary	Number of participants with diabetes		end of ultrasound
Secondary	Number of participants with reported nothing by mouth (NPO) status		end of ultrasound
Secondary	Pain severity as assessed by the numeric scale	This is a 11 point scale with scores ranging from 0 (no pain) to 10 (worst imaginable pain)	end of ultrasound
Secondary	Number of participants with Gastroesophageal reflux disease (GERD)		end of ultrasound
Secondary	Number of participants that have use opioids preoperatively		end of ultrasound