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

Aspiration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588495
• Other study ID #: 14-7883-BE
• Status: Completed
• Phase: N/A
• First received: October 26, 2015
• Last updated: November 21, 2017
• Start date: October 26, 2015
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aspiration

Intervention

Other:
• Food intake
Either drinking a cup of clear liquid, or having a cup of coffee and a muffin

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound's sensitivity to identify a "full stomach"	Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids	5 minutes
Secondary	Ultrasound's accuracy in detecting a "full stomach"	Assessing how accurate the Ultrasound machine is in detecting either liquid or solid contents in the participant's stomach after ingestion	5 minutes
Secondary	Inter/Intra-rater reliability of observer in detecting a "full stomach"	Determining the reliability of observers in being able to similarly detect a full stomach	5 minutes