NCT06941623

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

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: A Randomized Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Gastroesophageal Reflux

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasonography of gastric residual volume	Gastric ultrasound will be performed by the radiologist on each participant before the study and at 0, 10, 20, 30, 60, 90, 120 minutes after drinking in the position of head upright 45 degree with left lateral decubitus to evaluate the gastric residual volume and time to empty gastric antrum. If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.
DIAGNOSTIC_TEST	Point-of-care testing of glucose	We will perform the point-of-care test of glucose before the study and at 60, and 120 minutes after drinking.
OTHER	Hunger numeric rating scale	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.
OTHER	Thirst numeric rating scale	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.
OTHER	Nausea numeric rating scale	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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-05-19
• Completion: 2024-05-26
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: Thailand