MedDataX Logo

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

NCT ID: NCT02588495

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-26

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aspiration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ultrasound Gastric area Accuracy Aspirate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fasting

Participant will remain fasted following initial gastric ultrasound

Group Type NO_INTERVENTION

No interventions assigned to this group

Food intake

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

Group Type EXPERIMENTAL

Food intake

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Food intake

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anahi Perlas, MD

Role: PRINCIPAL_INVESTIGATOR

Staff Anesthesiologist

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.

Reference Type DERIVED
PMID: 29624530 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-7883-BE

Identifier Type: -

Identifier Source: org_study_id