Gastric Ultrasound for Estimation of the Aspiration Risk Study

NCT ID: NCT03310528

Last Updated: 2025-07-15

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

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-27

Study Completion Date

2026-07-14

Brief Summary

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

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.

Detailed Description

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

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.

Conditions

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

Respiratory Aspiration of Gastric Contents

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

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.

Interview questionnaire

Intervention Type BEHAVIORAL

Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Gastric ultrasound exam

Intervention Type PROCEDURE

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.

Interview questionnaire

Intervention Type BEHAVIORAL

Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Gastric ultrasound exam

Intervention Type PROCEDURE

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.

Interview questionnaire

Intervention Type BEHAVIORAL

Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Gastric ultrasound exam

Intervention Type PROCEDURE

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.

Interview questionnaire

Intervention Type BEHAVIORAL

Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Gastric ultrasound exam

Intervention Type PROCEDURE

Gastric ultrasound exam prior to upper GI endoscopy procedure.

Interventions

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

Interview questionnaire

Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Intervention Type BEHAVIORAL

Gastric ultrasound exam

Gastric ultrasound exam prior to upper GI endoscopy procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University of Florida

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.

Cameron Smith, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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

United States, Florida UF Health

Gainesville, Florida, United States

Site Status

Countries

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

United States

Other Identifiers

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

OCR18887

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201602234

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.