ClinicalTrials.gg
CompletedNCT03310528Updated Sep 22, 2026

Gastric Ultrasound for Estimation of the Aspiration Risk Study

An observational study in Respiratory Aspiration of Gastric Contents, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
18
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Respiratory Aspiration of Gastric Contents

Keywords

  • Aspiration risk
  • GI Endoscopy
  • Fasting guidelines
  • Delayed gastric emptying
03

In context

Respiratory Aspiration of Gastric Contents

27 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.

This study's enrollment of 18 is below the median of 100 across 11 observational studies indexed under Respiratory Aspiration of Gastric Contents.

Browse Respiratory Aspiration of Gastric Contents studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unwilling to undergo an ultrasound exam
  • Oral-gastric tube placement is not indicated
  • Oral-gastric tube placement is
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Procedure: Gastric ultrasound exam

  • 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 · Procedure: Gastric ultrasound exam

  • 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 · Procedure: Gastric ultrasound exam

  • 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 · Procedure: Gastric ultrasound exam

Interventions

  • BehavioralInterview questionnaire

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

  • ProcedureGastric ultrasound exam

    Gastric ultrasound exam prior to upper GI endoscopy procedure.

06

What researchers measure

Primary outcomes

  1. Changes in gastric content volume between the four groups assessed by ultrasound examination

    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.

    Time frame: Up to 12 hours

07

Study locations

1 site
  • United States, Florida UF Health
    Gainesville, Florida 32610-3003, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jul 2026, 99 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2017
First posted
Oct 16, 2017
StartActual
Mar 27, 2018
Primary completionActual
Jul 14, 2026
CompletionActual
Jul 14, 2026
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310528
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Mar 27, 2018
Primary completion
Jul 14, 2026
Completion
Jul 14, 2026
Last update
Sep 22, 2026

Study contacts

Cameron Smith, MD, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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