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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02588495
Other study ID # 14-7883-BE
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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