Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA)
研究概览
简要总结
The proposed study will use this technology to observe emptying of the stomach of a protein and carbohydrate rich clear liquid sports/nutrition drink.
详细描述
In order to ensure safety for elective anesthesia, standard practice requires pre-operative fasting to ensure that the stomach is empty prior to induction. The question of timing of pre-operative consumption of oral fluids remains vexed, and challenges anesthesiologists on a frequent basis. In the past few years, a new controversy in pre-operative fasting has arisen: clear drinks with increased content of protein and carbohydrate have been introduced to the market. Families and professionals alike are confused whether to regard these products as clear liquids (2 hours fasting) or as solids (at least 6 hours).
Ultrasound is now considered an accepted tool in the anesthesia literature as a surrogate for aspiration risk with different materials and in different disease states.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8-14 years old
- •Willing to not eat or drink for at least 8 hours overnight beforehand
- •Have a BMI < 35
排除标准
- •Use tobacco of any kind
- •Taking any medications (Females: oral contraceptives okay)
- •Suffers from diabetes, Crohn's Disease, Celiac Disease, Malabsorption, Galactosemia
- •Has ever has surgery on esophagus, stomach, or small bowel
- •Has allergies or intolerances to milk, apple juice, or ensure clear
- •Has any surgical condition, disease, or on any medication that could alter stomach emptying rate
- •Has any disease that limits day-to-day activities
- •Is pregnant or possibly could be pregnant
研究组 & 干预措施
2% Milk
16 participants will drink 10 ounces of 2% milk Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach
干预措施: Ultrasound (Procedure)
2% Milk
16 participants will drink 10 ounces of 2% milk Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach
干预措施: 2% milk (Other)
Apple Juice
16 participants will drink 10 ounces of apple juice Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach
干预措施: Ultrasound (Procedure)
Apple Juice
16 participants will drink 10 ounces of apple juice Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach
干预措施: apple juice (Other)
Ensure Clear
16 participants will drink 10 ounces of ensure clear Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach
干预措施: Ultrasound (Procedure)
Ensure Clear
16 participants will drink 10 ounces of ensure clear Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach
干预措施: ensure clear (Other)
结局指标
主要结局
Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA)
时间窗: Participants will be followed up to 6 hours after drinking 10 ounces of beverage
Subjective evolution of hunger after ingestion of clear fluids using a validated visual analog scale called the Hunger Satiety Score
时间窗: Participants will be followed up to 6 hours after drinking 10 ounces of beverage
次要结局
未报告次要终点