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Gastric Ultrasound for Estimation of the Aspiration Risk Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03310528
Enrollment
200
Registered
2017-10-16
Start date
2018-03-27
Completion date
2026-07-14
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Aspiration of Gastric Contents

Keywords

Aspiration risk, GI Endoscopy, Fasting guidelines, Delayed gastric emptying

Brief 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.

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.

Interventions

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

Gastric ultrasound exam prior to upper GI endoscopy procedure.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in gastric content volume between the four groups assessed by ultrasound examinationUp to 12 hoursEvaluate 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026