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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Gastric Residual Volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Ultrasonography of gastric residual volume (Diagnostic Test)
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)
干预措施: Point-of-care testing of glucose (Diagnostic Test)
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)
干预措施: Hunger numeric rating scale (Other)
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)
干预措施: Thirst numeric rating scale (Other)
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)
干预措施: Nausea numeric rating scale (Other)
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)
干预措施: Ultrasonography of gastric residual volume (Diagnostic Test)
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)
干预措施: Point-of-care testing of glucose (Diagnostic Test)
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)
干预措施: Hunger numeric rating scale (Other)
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)
干预措施: Thirst numeric rating scale (Other)
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)
干预措施: Nausea numeric rating scale (Other)
结局指标
主要结局
Gastric Residual Volume
时间窗: 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
次要结局
- Time to empty gastric antrum(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.)
- Point-of-care testing(POCT) glucose(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)(before the study, 60, and 120 minutes after drinking the prepared drink each arm)
- Thirst Numeric Rating Scale(NRS)(before the study, 60, and 120 minutes after drinking the prepared drink each arm)
- Nausea Numeric Rating Scale(NRS)(before the study, 60, and 120 minutes after drinking the prepared drink each arm)
研究者
Chanya Deekiatphaiboon
Anesthesiology department, Faculty of Medicine
Prince of Songkla University