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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to empty gastric antrum | Duration after drinking the drink until the gastric antrum cross-sectional area < 1.5 ml/kg measure by ultrasound | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chanya Deekiatphaiboon | Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Songklanagarind Hospital | Hat Yai | Changwat Songkhla | 90110 | Thailand |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Point-of-care testing(POCT) glucose |
measured by point-of-care testing(POCT) glucose at every 60 minutes entire the study |
| 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) | 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. | before the study, 60, and 120 minutes after drinking the prepared drink each arm |
| Thirst Numeric Rating Scale(NRS) | 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. | before the study, 60, and 120 minutes after drinking the prepared drink each arm |
| Nausea Numeric Rating Scale(NRS) | 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. | before the study, 60, and 120 minutes after drinking the prepared drink each arm |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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