Diagnostic Performance of the Ultrasound Examination of the Antrum to Detect a Full Stomach According to the Position of the Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Calculation of the sensitivity
研究概览
简要总结
Pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. Ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. In particular, this examination is based on the qualitative analysis of gastric contents performed in the supine and in the right lateral decubitus, using a qualitative score which makes it possible to discriminate a low liquid content of a large liquid volume. This score has been described in patients and volunteers installed on a bed without elevation of the upper section of the bed. However, in several studies, this qualitative score has been achieved in the 45° semirecumbent position, which may have affected the diagnostic performance of the examination thus performed, as suggested by the results of a study recently conducted by the investigating team. This study therefore aims to compare the diagnostic performance of the qualitative analysis of the gastric antrum performed in the supine and the right lateral decubitus for the diagnosis of gastric volumes higher than 50 ml and 100 ml, according to the bed angle: 45 ° elevation or no elevation of the upper section of the bed.
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
- None
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
- •Adults 18 years old or older
- •Last consumption of solids at least 6 hours before the start of the study, last consumption of clear fluids at least 2 hours before the start of the study
- •Informed consent must have been signed.
- •No significant medical history (American Society of Anesthesiologists (ASA) class 1)
排除标准
- •Adult unable to give informed consent
- •Previous gastrointestinal surgery
- •Medication affecting gastric motility
- •Digestive diseases, gastroparesis, diabetes mellitus with insulin
- •Pregnancy or breastfeeding
- •Obesity (Body Mass Index (BMI) ≥ 30 kilograms/meter² (kg/m²))
结局指标
主要结局
Calculation of the sensitivity
时间窗: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the 45° semirecumbent position.
次要结局
- Calculation of the specificity(3 minutes)
- Cut-off value for antral area measured in the supine position (semirecumbent or full supine position) associated with the best diagnostic performance for the detection of a gastric volume ≥1.5 milliliters/kilogram (ml/kg).(3 minutes)
- Calculation of the positive and negative likelihood ratio.(3 minutes)
- Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation(3 minutes)
- Calculation of the positive predictive value,(3 minutes)
- Calculation of the negative predictive value(3 minutes)
- Mathematical model for the calculation of the gastric fluid volume(3 minutes)
- Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position(3 minutes)