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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02888951
• Other study ID #: 15-8808-AE
• Status: Recruiting
• Start date: August 2016
• Est. completion date: January 2021

Study information

• Verified date: February 2019
• Source: University Health Network, Toronto
• Contact: Anahi Perlas, MD
• Phone: (416) 603-5800
• Email: anahi.perlas[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Episodes of intra-operative regurgitation, vomiting or aspiration	Episodes of intra-operative regurgitation, vomiting or aspiration	Intraoperative