Do Standard Preoperative Fasting Instructions Ensure an Empty Stomach in Diabetic Patients? A Prospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Volume of Gastric Contents
研究概览
简要总结
This study evaluates the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures.
详细描述
Any surgical procedure carries an inherent risk of pulmonary aspiration. Food or liquid from the stomach might be forced back up the throat from where it could enter the lungs (aspiration) resulting in serious complications prolonging the hospital stay or in extreme circumstances death.
The risk of this is slightly higher in diabetics when compared to non-diabetics as the emptying of contents from the stomach is slightly delayed. This is why people going for surgery are asked not to eat for a specific time before their surgery. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.
This study aims to evaluate the amount of fluid remaining in the stomach of diabetic patients after a standard fasting period, and compare it with non-diabetic patients coming for elective surgical procedures. The investigators also aim to find an association between the type and duration of diabetes mellitus with residual gastric volume. Episodes of intra-operative regurgitation, vomiting or aspiration will also be documented.
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
- •Patients scheduled for elective surgery aged 18 to 85 years
- •American Society of Anesthesia physical status classification I to III
- •Body mass index < 40 kg/ cm2.
排除标准
- •Pregnancy (currently or within the past 3 months)
- •Previous surgery of the upper gastrointestinal tract
- •Achalasia
结局指标
主要结局
Volume of Gastric Contents
时间窗: Less than two hour prior to surgery
A "full stomach" is defined as one containing a) solid or thick fluid content or b) \> 1.5 mL/kg of clear fluid. There are 4 categories regarding gastric contents: 1. Empty Stomach 2. Grade 1 Clear Fluid (fluid only observed in supine or right lateral decubitus position) 3. Grade 2 Clear Fluid (fluid only observed in both supine and right lateral decubitus position) 4. Solid
次要结局
- Define the upper limit of normal fasting gastric volume defined as the 95th percentile(Less than two hour prior to surgery)
- Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients(Less than two hour prior to surgery)
- Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients(Less than two hour prior to surgery)
- Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes.(Less than two hour prior to surgery)
- Episodes of intra-operative regurgitation, vomiting or aspiration(Intraoperative)