Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Ultrasound's sensitivity to identify a "full stomach"
研究概览
简要总结
During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.
The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 18 to 85 years
- •Male or female
- •American Society of Anesthesia physical status classification I and II
- •Height greater than 145 cm
- •Ability to understand the study protocol and provide informed consent
排除标准
- •Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
- •History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)
研究组 & 干预措施
Fasting
Participant will remain fasted following initial gastric ultrasound
Food intake
Participant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound
干预措施: Food intake (Other)
结局指标
主要结局
Ultrasound's sensitivity to identify a "full stomach"
时间窗: 5 minutes
Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids
次要结局
- Ultrasound's accuracy in detecting a "full stomach"(5 minutes)
- Inter/Intra-rater reliability of observer in detecting a "full stomach"(5 minutes)