Gastric Ultrasound for Estimation of the Aspiration Risk Study

July 10, 2025 updated by: University of Florida

Gastric Ultrasound for Estimation of the Aspiration Risk in High Aspiration-risk Surgical Patient Populations

The purpose of this research study is to look at the effectiveness of current anesthesia guidelines regarding food and drink prior to surgery in patients who are likely to have food and drink remain in their stomach longer than might ordinarily be expected.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Examine the utility of ultrasound examination of the stomach in estimating aspiration risk in patient populations whose aspiration risk is currently poorly understood. Evaluate the applicability of current pre-surgical fasting guidelines in the same patient populations whose aspiration risk is poorly understood.

Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have adhered to pre-operative fasting guidelines. Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures who have not adhered to pre-operative fasting guidelines. Only patients expected to have an oral-gastric tube placed during upper GI endoscopy procedure will be included. Both groups will be evaluated to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-3003
        • United States, Florida UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for upper GI endoscopy and/or endoscopic retrograde cholangiopancreatogram (ERCP), expected to have an oral-gastric tube placed as part of scheduled procedure.

Description

Inclusion Criteria:

  • Presenting for upper GI endoscopy procedures or surgical repair of a trauma- related injury
  • Expected to have an oral-gastric tube placed as part of scheduled procedure
  • Willing to undergo an ultrasound exam
  • Patients ≥ 18 years of age

Exclusion Criteria:

  • Unwilling to undergo an ultrasound exam
  • Oral-gastric tube placement is not indicated
  • Oral-gastric tube placement is contraindicated
  • Pregnant patients and patients from defined vulnerable populations (ex. pediatric patients, mentally handicapped patients, prisoners, etc.)
  • Surgical trauma patients who are not expected to have an OG tube placed during surgery
  • Patients with history of gastric bypass surgery
  • Patients that are gastrostomy tube dependent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obeyed fasting guidelines
Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Behavioral: Interview questionnaire
Complete interview questionnaire regarding the composition and timing of their most recent food intake.
Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.
Did not obey fasting guidelines
Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Behavioral: Interview questionnaire
Complete interview questionnaire regarding the composition and timing of their most recent food intake.
Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.
Trauma - obeyed fasting guidelines
Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Behavioral: Interview questionnaire
Complete interview questionnaire regarding the composition and timing of their most recent food intake.
Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.
Trauma - did not obey fasting guidelines
Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Behavioral: Interview questionnaire
Complete interview questionnaire regarding the composition and timing of their most recent food intake.
Procedure: Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gastric content volume between the four groups assessed by ultrasound examination
Time Frame: Up to 12 hours
Evaluate the residual gastric contents in patients presenting for upper GI endoscopy procedures to learn if their residual gastric contents conform to currently-accepted standards for low aspiration risk.
Up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Cameron Smith, MD, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2018

Primary Completion (Estimated)

July 14, 2026

Study Completion (Estimated)

July 14, 2026

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201602234
  • OCR18887 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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