A Cohort Study of Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Prevalence of full stomach
研究概览
简要总结
This is a prospective cohort study. The main objective is to compare the prevalence of a "full stomach" using gastric ultrasound technique, in elective surgical patients with diabetes mellitus compared to non-diabetic controls following the present fasting guidelines (2 h after clear liquid and 6h after a light meal). For patients with a full stomach or intermediate stomach, an consecutive ultrasound scan is performed every 10 min,until empty stomachstomach contents are detected to determine the mean gastric emptying time for clear liquid and light meal, and to investigate the risk factors for delayed stomach emptying in diabetic patients by logistic regression analysis .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes (two fasting plasma glucose concentration≥7mmol/L or casual plasma glucose concentration≥11.1mmol/L);
- •age≥18 yr; ASA physical status I-III;
- •body mass index <35kg/m2;
- •who are admitted to the surgical department;
- •who are able to understand the rationale of the study and provide informed consent.
排除标准
- •pregnancy;
- •a history of upper gastrointestinal disease or previous surgery on the oesophagus, stomach or upper abdomen;
- •documented abnormalities of the upper gastrointestinal tract such as gastric tumors;
- •recent upper gastrointestinal bleeding (within the preceding 1 month);
- •taking medicines that may delay gastric emptying(e.g., anticholinergic agents).
- •hypothyroidism.
结局指标
主要结局
Prevalence of full stomach
时间窗: one day
The frequency of a "full stomach" in the diabetic population compared to a non-diabetic control population at 2h after ingesting clear liquid or 6h after light meal.
次要结局
- Mean gastric emptying time of clear liquid and light meal(one day)
研究者
Chunling Jiang
Professor
West China Hospital