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

NCT ID: NCT06941623

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-05-26

Brief Summary

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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

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Conditions

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Obesity Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Carbohydrate drink

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)

Group Type EXPERIMENTAL

Ultrasonography of gastric residual volume

Intervention Type 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.

Point-of-care testing of glucose

Intervention Type DIAGNOSTIC_TEST

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

Hunger numeric rating scale

Intervention Type 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.

Thirst numeric rating scale

Intervention Type 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.

Nausea numeric rating scale

Intervention Type 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.

Water

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)

Group Type PLACEBO_COMPARATOR

Ultrasonography of gastric residual volume

Intervention Type 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.

Point-of-care testing of glucose

Intervention Type DIAGNOSTIC_TEST

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

Hunger numeric rating scale

Intervention Type 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.

Thirst numeric rating scale

Intervention Type 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.

Nausea numeric rating scale

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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GRV POCT glucose, DTX Hunger NRS Thirst NRS Nausea NRS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Chanya Deekiatphaiboon

Anesthesiology department, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chanya Deekiatphaiboon

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

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Faculty of medicine, Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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REC 66-538-8-1

Identifier Type: -

Identifier Source: org_study_id

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