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
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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COMPLETED
NA
22 participants
INTERVENTIONAL
2023-02-01
2024-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
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)
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.
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.
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.
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.
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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Prince of Songkla University
OTHER
Responsible Party
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Chanya Deekiatphaiboon
Anesthesiology department, Faculty of Medicine
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
Countries
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Other Identifiers
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REC 66-538-8-1
Identifier Type: -
Identifier Source: org_study_id
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