Clinical trial NCT02888951: Gastric Ultrasound of Diabetic and Non-Diabetic Patients Following Preoperative Fasting Instructions
Official title: Do Standard Preoperative Fasting Instructions Ensure an Empty Stomach in Diabetic Patients? A Prospective Comparative Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Diabetes Mellitus
Diabetes Mellitus Type 1
Diabetes Mellitus Type 2
Keywords: Diabetes
Diabetes Mellitus
Gastric Ultrasound
Preoperative fasting
Empty Stomach
Gastric Diabetes
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Volume of Gastric Contents
timeFrame: Less than two hour prior to surgery
Secondary outcomes:
measure: Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients
timeFrame: Less than two hour prior to surgery
measure: Define the upper limit of normal fasting gastric volume defined as the 95th percentile
timeFrame: Less than two hour prior to surgery
measure: Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients
timeFrame: Less than two hour prior to surgery
measure: Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes.
timeFrame: Less than two hour prior to surgery
measure: Episodes of intra-operative regurgitation, vomiting or aspiration
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References: