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

January 14, 2020 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anahi Perlas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of Gastric Contents
Time Frame: 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
Less than two hour prior to surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of baseline gastric volume in fasted diabetic and non-diabetic patients
Time Frame: Less than two hour prior to surgery
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
Time Frame: 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
Time Frame: 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
Less than two hour prior to surgery
Gastric volume of diabetic patients in relation with the medication/therapy used manage their diabetes.
Time Frame: 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.
Less than two hour prior to surgery
Episodes of intra-operative regurgitation, vomiting or aspiration
Time Frame: Intraoperative
Episodes of intra-operative regurgitation, vomiting or aspiration
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (ESTIMATE)

September 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-8808-AE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is undecided at this time whether data will be shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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