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

NCT ID: NCT02888951

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Diabetes Diabetes Mellitus Diabetes Mellitus Type 1 Diabetes Mellitus Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic Group

A group of diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure.

No interventions assigned to this group

Non-Diabetic Group

A group of non-diabetic patients who have fasted for at least 8 hours undergoing an elective surgical procedure.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anahi Perlas, MD

Role: CONTACT

(416) 603-5800 ext. 5118

Didem Bozak

Role: CONTACT

(416) 603-5800 ext. 2016

Facility Contacts

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Anahi Perlas, MD

Role: primary

(416) 603-5800 ext. 5118

Didem Bozak

Role: backup

(416) 603-5800 ext. 2016

Other Identifiers

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15-8808-AE

Identifier Type: -

Identifier Source: org_study_id

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