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

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

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.

Sponsors & Collaborators

• Prince of Songkla University

  lead OTHER

Principal Investigators

• Chanya Deekiatphaiboon · Prince of Songkla University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2024-05-19

Completion

2024-05-26

Countries

• Thailand

Study Locations