Diabetes, Diabetes Mellitus, Diabetes Mellitus Type 1, Diabetes Mellitus Type 2
Conditions
Keywords
Diabetes, Diabetes Mellitus, Gastric Ultrasound, Preoperative fasting, Empty Stomach, Gastric Diabetes
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.
Interventions
None listed
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Gastric Contents | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients | Less than two hour prior to surgery | Characterize the distribution of baseline gastric volume in fasted diabetic and non-diabetic patients |
| Define the upper limit of normal fasting gastric volume defined as the 95th percentile | Less than two hour prior to surgery | Define the upper limit of normal fasting gastric volume defined as the 95th percentile |
| Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients | Less than two hour prior to surgery | To study the association between type of diabetes mellitus (I or II), duration and degree of glycemic control with baseline gastric fluid volume |
| Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes. | Less than two hour prior to surgery | 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. |
| Episodes of intra-operative regurgitation, vomiting or aspiration | Intraoperative | Episodes of intra-operative regurgitation, vomiting or aspiration |
Countries
Canada
Contacts
Primary ContactAnahi Perlas, MD
Backup ContactDidem Bozak
Outcome results
None listed