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Completed

NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GRV

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.

Other names: POCT glucose, DTX

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.

Other names: Hunger NRS

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.

Other names: Thirst NRS

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.

Other names: Nausea NRS

Primary outcomes

  1. Gastric Residual Volume

    Time frame: 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 outcomes

  1. Time to empty gastric antrum

    Time frame: 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

  2. Point-of-care testing(POCT) glucose

    Time frame: 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

  3. Hunger Numeric Rating Scale(NRS)

    Time frame: 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.

  4. Thirst Numeric Rating Scale(NRS)

    Time frame: 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.

  5. Nausea Numeric Rating Scale(NRS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Acronym: CarbDrinkUltra

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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