Gastric Ultrasound for Estimation of the Aspiration Risk Study

Recruiting

• Conditions: Respiratory Aspiration of Gastric Contents
• Interventions: Behavioral: Interview questionnaire; Procedure: Gastric ultrasound exam

• Registration Number: NCT03310528
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-16
• Study Start: 2018-03-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-07-14
• Study Completion: 2026-07-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trauma - did not obey fasting guidelines	Interview questionnaire	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Did not obey fasting guidelines	Interview questionnaire	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Trauma - did not obey fasting guidelines	Gastric ultrasound exam	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Obeyed fasting guidelines	Interview questionnaire	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Trauma - obeyed fasting guidelines	Gastric ultrasound exam	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Obeyed fasting guidelines	Gastric ultrasound exam	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Did not obey fasting guidelines	Gastric ultrasound exam	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.
Trauma - obeyed fasting guidelines	Interview questionnaire	Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Primary Outcome Measures

Name	Time	Method
Changes in gastric content volume between the four groups assessed by ultrasound examination	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.

Trial Locations

Locations (1)

United States, Florida UF Health; 🇺🇸 Gainesville, Florida, United States