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

Not Applicable

Completed

• Conditions: Aspiration

• Registration Number: NCT02588495
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-26
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ultrasound's sensitivity to identify a "full stomach"	5 minutes	Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids

Secondary Outcome Measures

Name	Time	Method
Ultrasound's accuracy in detecting a "full stomach"	5 minutes	Assessing how accurate the Ultrasound machine is in detecting either liquid or solid contents in the participant's stomach after ingestion
Inter/Intra-rater reliability of observer in detecting a "full stomach"	5 minutes	Determining the reliability of observers in being able to similarly detect a full stomach

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada