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Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Aspiration

Treatments

Other: Food intake

Study type

Interventional

Funder types

Other

Identifiers

NCT02588495
14-7883-BE

Details and patient eligibility

About

During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. 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.

The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.

Enrollment

80 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers aged 18 to 85 years
  • Male or female
  • American Society of Anesthesia physical status classification I and II
  • Height greater than 145 cm
  • Ability to understand the study protocol and provide informed consent

Exclusion criteria

  • Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
  • History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Fasting
No Intervention group
Description:
Participant will remain fasted following initial gastric ultrasound
Food intake
Experimental group
Description:
Participant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound
Treatment:
Other: Food intake

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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