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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Group | A group of diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. | ||
| Non-Diabetic Group | A group of non-diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure. |
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| 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:
| Less than two hour prior to surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be patients whom are scheduled to undergo elective surgical procedures requiring preoperative fasting period of at least 8 hours. 240 patients will be recruited in total. One cohort consisting 120 patients will be diabetic (type 1 or 2). The other cohort consisting of 120 patients will be non-diabetic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anahi Perlas, MD | Contact | (416) 603-5800 | 5118 | anahi.perlas@uhn.ca |
| Didem Bozak | Contact | (416) 603-5800 | 2016 | didem.bozak@uhnresearch.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
It is undecided at this time whether data will be shared.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |