Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects. ECHO3DGASTRIQUE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- success rate of ultrasound visualization of the stomach while fasting
研究概览
简要总结
Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to passage of the gastric contents into the unprotected upper airways during general anaesthesia. The prognosis depends on three factors: the presence of food debris, and the acidity and volume of the gastric contents. To prevent this complication, the French society of anaesthesia and intensive care recommends preoperative fasting rules and, in patients presenting risk factors for aspiration, the use of antacids and rapid sequence intubation. This preventive strategy is associated with certain adverse events: deferred operative procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic complications, and memory of anaesthetic induction.
Over recent years, ultrasound has become more widely used by anaesthetists for local anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of intragastric volume presents several limitations: because of the complex shape of the stomach, this technique requires a long learning curve and the measured volume is poorly correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently measured intragastric volume by three dimensional ultrasound with promising results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers over the age of 18 years employed by Amiens University Hospital and covered by French national health insurance.
- •Fasting (last meal > 6 hours and last drink of water, tea or coffee > 2 hours)
- •Signature of the free and informed written consent form.
排除标准
- •Pregnant woman.
- •Presence of diseases or treatments that alter (slow or accelerate) gastric emptying.
- •Presence of swallowing disorders.
- •History of gastric or supramesocolic surgery.
结局指标
主要结局
success rate of ultrasound visualization of the stomach while fasting
时间窗: Day 0
success rate of ultrasound visualization of the stomach while fasting
次要结局
- ultrasound visualization of the fasting stomach learning curve(Day 0)
- measured difference of antral surface area(Day 0)
- absolute error of the volume measured(Day 0)
- relative error of the volume measured(Day 0)
