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 (CarbDrinkUltra)

Prince of Songkla University

Status: Completed

Conditions: Gastroesophageal Reflux; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06941623

REC 66-538-8-1

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Carbohydrate drink

Experimental group

Description:

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)

Treatment:

Diagnostic Test: Point-of-care testing of glucose

Other: Thirst numeric rating scale

Diagnostic Test: Ultrasonography of gastric residual volume

Other: Nausea numeric rating scale

Other: Hunger numeric rating scale

Water

Placebo Comparator group

Description:

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)

Treatment:

Diagnostic Test: Point-of-care testing of glucose

Other: Thirst numeric rating scale

Diagnostic Test: Ultrasonography of gastric residual volume

Other: Nausea numeric rating scale

Other: Hunger numeric rating scale