Gastric Ultrasound for Estimation of the Aspiration Risk Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Aspiration of Gastric Contents

Intervention / Treatment
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* Behavioral: Interview questionnaire
* Procedure: Gastric ultrasound exam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obeyed fasting guidelines<br>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<br>* Complete interview questionnaire regarding the composition and timing of their most recent food intake.<br>Procedure: Gastric ultrasound exam<br>* Gastric ultrasound exam prior to upper GI endoscopy procedure.<br>|
| Did not obey fasting guidelines<br>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<br>* Complete interview questionnaire regarding the composition and timing of their most recent food intake.<br>Procedure: Gastric ultrasound exam<br>* Gastric ultrasound exam prior to upper GI endoscopy procedure.<br>|
| Trauma - obeyed fasting guidelines<br>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<br>* Complete interview questionnaire regarding the composition and timing of their most recent food intake.<br>Procedure: Gastric ultrasound exam<br>* Gastric ultrasound exam prior to upper GI endoscopy procedure.<br>|
| Trauma - did not obey fasting guidelines<br>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<br>* Complete interview questionnaire regarding the composition and timing of their most recent food intake.<br>Procedure: Gastric ultrasound exam<br>* Gastric ultrasound exam prior to upper GI endoscopy procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspiration risk, GI Endoscopy, Fasting guidelines, Delayed gastric emptying