Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration

Not Applicable

Completed

• Conditions: Obesity; Gastroesophageal Reflux

• Registration Number: NCT06941623
• Lead Sponsor: Prince of Songkla University

Brief Summary

The goal of this clinical trial is to compare gastric residual volume between drinking a carbohydrate drink and water in obesity class II and III volunteers at risk of aspiration.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-03-08
• Primary Completion: 2024-05-19
• Study Completion: 2024-05-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• BMI ≥ 35 kg/m2 (obesity class II and III)
• Gastroesophageal reflux disease and/or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation)
• ASA status I-III
• NPO for 8 hours before the study

Exclusion Criteria

• Chronic kidney disease or End-stage renal disease
• Diabetes Mellitus
• Use of any medication that affects gastric secretion or emptying within the past 24-hour
• Pregnancy
• History of major upper gastrointestinal surgery
• Allergy to ultrasound gel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gastric Residual Volume	before the study and 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm.If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.	gastric ultrasound at the gastric antrum by ultrasound

Secondary Outcome Measures

Name	Time	Method
Time to empty gastric antrum	0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm. If participants doesn't be empty stomach, time will extended to 120 and 180 minutes.	Duration after drinking the drink until the gastric antrum cross-sectional area \< 1.5 ml/kg measure by ultrasound
Point-of-care testing(POCT) glucose	Point-of-care testing(POCT) glucose is measured before the study, 60 and 120 after drinking the prepared drink each arm.	measured by point-of-care testing(POCT) glucose at every 60 minutes entire the study
Hunger Numeric Rating Scale(NRS)	before the study, 60, and 120 minutes after drinking the prepared drink each arm	Hunger will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of hunger levels, defined by numbers from 0 to 10, where 0 represents the lowest level of hunger and 10 represents the highest.
Thirst Numeric Rating Scale(NRS)	before the study, 60, and 120 minutes after drinking the prepared drink each arm	Thirst will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of thirst levels, defined by numbers from 0 to 10, where 0 represents the lowest level of thirst and 10 represents the highest.
Nausea Numeric Rating Scale(NRS)	before the study, 60, and 120 minutes after drinking the prepared drink each arm	Nausea will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of nausea levels, defined by numbers from 0 to 10, where 0 represents the lowest level of nausea and 10 represents the highest.

Trial Locations

Locations (1)

Faculty of medicine, Songklanagarind Hospital; 🇹🇭 Hatyai, Songkhla, Thailand