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

NCT02888951 | Unknown

• 1 other identifier: 15-8808-AE
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus; Diabetes Mellitus Type 1; Diabetes Mellitus Type 2

Keywords

Diabetes; Diabetes Mellitus; Gastric Ultrasound; Preoperative fasting; Empty Stomach; Gastric Diabetes

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Less than two hour prior to surgery

Secondary Outcomes (5)

• 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

  Less than two hour prior to surgery

• Duration and degree of glycemic control with baseline gastric fluid volume amongst diabetic patients

  Less than two hour prior to surgery

• Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes.

  Less than two hour prior to surgery

• Episodes of intra-operative regurgitation, vomiting or aspiration

  Intraoperative

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy (currently or within the past 3 months)
• Previous surgery of the upper gastrointestinal tract
• Achalasia

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Anahi Perlas, MD

CONTACT

(416) 603-5800; anahi.perlas@uhn.ca

Didem Bozak

CONTACT

(416) 603-5800; didem.bozak@uhnresearch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 5, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2019-02

Locations

CA (1)