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临床试验/NCT02819466
NCT02819466已完成不适用

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

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年4月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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