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

NCT06941623 | Completed DMC

• 1 other identifier: REC 66-538-8-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Gastroesophageal Reflux

Keywords

Carbohydrate drink; Gastric residual volume; Gastric ultrasound

Outcome Measures

Primary Outcomes (1)

• Gastric Residual Volume

  gastric ultrasound at the gastric antrum by ultrasound

  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.

Secondary Outcomes (5)

• 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.

• 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.

• Hunger Numeric Rating Scale(NRS)

  before the study, 60, and 120 minutes after drinking the prepared drink each arm

• Thirst Numeric Rating Scale(NRS)

  before the study, 60, and 120 minutes after drinking the prepared drink each arm

• Nausea Numeric Rating Scale(NRS)

  before the study, 60, and 120 minutes after drinking the prepared drink each arm

Study Arms (2)

Carbohydrate drink

EXPERIMENTAL

Volunteers receive a carbohydrate drink of 400 ml (50 g of glucose, clear color, same appearance, and containing bottles of water, prepared by the nutrition division, Songklanagarind hospital)

Diagnostic Test: Ultrasonography of gastric residual volume; Diagnostic Test: Point-of-care testing of glucose; Other: Hunger numeric rating scale; Other: Thirst numeric rating scale; Other: Nausea numeric rating scale

Water

PLACEBO COMPARATOR

Volunteers receive a bottle of 400 ml water (clear color, same appearance, and containing bottles of carbohydrate drink, prepared by the nutrition division, Songklanagarind hospital)

Diagnostic Test: Ultrasonography of gastric residual volume; Diagnostic Test: Point-of-care testing of glucose; Other: Hunger numeric rating scale; Other: Thirst numeric rating scale; Other: Nausea numeric rating scale

Interventions

Ultrasonography of gastric residual volume DIAGNOSTIC_TEST

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.

Also known as: GRV

Carbohydrate drink; Water

Point-of-care testing of glucose DIAGNOSTIC_TEST

We will perform the point-of-care test of glucose before the study and at 60, and 120 minutes after drinking.

Also known as: POCT glucose, DTX

Carbohydrate drink; Water

Hunger numeric rating scale OTHER

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.

Also known as: Hunger NRS

Carbohydrate drink; Water

Thirst numeric rating scale OTHER

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.

Also known as: Thirst NRS

Carbohydrate drink; Water

Nausea numeric rating scale OTHER

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.

Also known as: Nausea NRS

Carbohydrate drink; Water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of medicine, Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Chanya Deekiatphaiboon

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology department, Faculty of Medicine

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 24, 2025
• Study Start: February 1, 2023
• Primary Completion: May 19, 2024
• Study Completion: May 26, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)