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

University Health Network, Toronto logo

University Health Network, Toronto

Status

Unknown

Conditions

Diabetes
Diabetes Mellitus Type 2
Diabetes Mellitus
Diabetes Mellitus Type 1

Study type

Observational

Funder types

Other

Identifiers

NCT02888951
15-8808-AE

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Didem Bozak; Anahi Perlas, MD

Data sourced from clinicaltrials.gov

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