Patient Satiety as an Indicator of Stomach Contents and Fluid Volume: an Observational Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- the correlation between total gastric fluid volume in millilitres and a ten-point (0-10) satiety scale.
研究概览
简要总结
This research proposal aims to investigate the correlation between a) the hunger feeling as measured by a ten point scale and b) total gastric fluid volumes and content as measured with gastric PoCUS in fasted, healthy subjects > 18 of age, scheduled for elective surgery.
详细描述
An ultrasound exam will be performed before induction of anaesthesia. GUS results from selected patients will be systematically acquired and assessed following an algorithm (Appendix Ia). The ultrasound results will be collected on a standardized form (Appendix IIa). The technique is performed in the supine and right lateral decubitus position (Appendix Ib) and only by anesthesiologists with sufficient experience with ultrasound and the technique. The patient will be asked to indicate his/her satiety on a predetermined ten-point scale. Patient data and satiety score will be collected on a standardized form (Appendix IIb). The scanning anaesthesiologist is blinded to the result of the questionnaire.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age ≥ 18 years
- •Fasted according to national guidelines
- •Elective surgery
- •ASA physical status I-II
- •Ability to assume both supine and right lateral decubitus position.
- •Able to understand and to sign informed consent
排除标准
- •- Previous esophagus and gastric surgery, hiatal hernia, gastric cancer.
- •Pregnancy
- •Failure of GUS (defined as failure to visualize the antrum)
结局指标
主要结局
the correlation between total gastric fluid volume in millilitres and a ten-point (0-10) satiety scale.
时间窗: Before surgery
total gastric fluid volumes are measured with gastric point-of-care ultrasound, satiety is measured with a 0 to 10 scale. Zero stands for no satiety ( very hungry, thirsty), ten stands for fully satisfied ( no hunger or thirst).
次要结局
- the correlation between the type of gastric content ( no content, fluid content, solid content) and a ten-point (0-10) satiety scale(before surgery)
- the correlation between the Perlas grading scale ( 0,1,2) and a ten-point (0-10) satiety scale.(Before surgery)
研究者
Peter Van de Putte
Principal investigator, MD PhD
Imeldaziekenhuis