Gastric Ultrasound of Diabetic and Non-Diabetic Patients Following Preoperative Fasting Instructions

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Do Standard Preoperative Fasting Instructions Ensure an Empty Stomach in Diabetic Patients? A Prospective Comparative Cohort Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Diabetes Mellitus Type 1, Diabetes Mellitus Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Pregnancy (currently or within the past 3 months) Previous surgery of the upper gastrointestinal tract Achalasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic Group<br>A group of diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. | |
| Non-Diabetic Group<br>A group of non-diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Gastric Contents | 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: Empty Stomach Grade 1 Clear Fluid (fluid only observed in supine or right lateral decubitus position) Grade 2 Clear Fluid (fluid only observed in both supine and right lateral decubitus position) Solid | Less than two hour prior to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients | Characterize the distribution of baseline gastric volume in fasted diabetic and non-diabetic patients | Less than two hour prior to surgery | 
| Define the upper limit of normal fasting gastric volume defined as the 95th percentile | Define the upper limit of normal fasting gastric volume defined as the 95th percentile | Less than two hour prior to surgery | 
| Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients | To study the association between type of diabetes mellitus (I or II), duration and degree of glycemic control with baseline gastric fluid volume | Less than two hour prior to surgery | 
| Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes. | To study the relationship between gastric volume in diabetic patients in relation with which medication and/or treatment they use to manage their diabetes. Examples of medication or treatment include; pharmaceutical hypoglycemics, insulin, or diet controlled. | Less than two hour prior to surgery | 
| Episodes of intra-operative regurgitation, vomiting or aspiration | Episodes of intra-operative regurgitation, vomiting or aspiration | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Diabetes Mellitus, Gastric Ultrasound, Preoperative fasting, Empty Stomach, Gastric Diabetes