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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT02588495
Collaborator
(none)
80
1
2
19.2
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Food intake
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
Actual Study Start Date :
Oct 26, 2015
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Fasting

Participant will remain fasted following initial gastric ultrasound

Experimental: Food intake

Participant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Western Hospital Toronto Ontario Canada M5T 2S8

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Anahi Perlas, MD, Staff Anesthesiologist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02588495
Other Study ID Numbers:
  • 14-7883-BE
First Posted:
Oct 27, 2015
Last Update Posted:
Nov 24, 2017
Last Verified:
Nov 1, 2017
Keywords provided by University Health Network, Toronto

Study Results

No Results Posted as of Nov 24, 2017