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OpenTrials
Active, Not Recruiting

NCT Number: NCT03310528

Gastric Ultrasound for Estimation of the Aspiration Risk Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interview questionnaire

Behavioral

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

Gastric ultrasound exam

Procedure

Gastric ultrasound exam prior to upper GI endoscopy procedure.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2017
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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