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OpenTrials
Completed

NCT Number: NCT02588495

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

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.

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Key information

Conditions

Aspiration

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

food intake

Other

Either drinking a cup of clear liquid, or having a cup of coffee and a muffin

Primary outcomes

  1. Ultrasound's sensitivity to identify a "full stomach"

    Time frame: 5 minutes

    Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids

Secondary outcomes

  1. Ultrasound's accuracy in detecting a "full stomach"

    Time frame: 5 minutes

    Assessing how accurate the Ultrasound machine is in detecting either liquid or solid contents in the participant's stomach after ingestion

  2. Inter/Intra-rater reliability of observer in detecting a "full stomach"

    Time frame: 5 minutes

    Determining the reliability of observers in being able to similarly detect a full stomach

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2015
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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