Gastric Ultrasound for Estimation of the Aspiration Risk Study

University of Florida

Status: Enrolling

Conditions: Respiratory Aspiration of Gastric Contents

Treatments: Behavioral: Interview questionnaire; Procedure: Gastric ultrasound exam

Study type: Observational

Funder types: Other

Identifiers

NCT03310528

OCR18887 (Other Identifier)

IRB201602234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

Obeyed fasting guidelines

Description:

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Treatment:

Procedure: Gastric ultrasound exam

Behavioral: Interview questionnaire

Did not obey fasting guidelines

Description:

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Treatment:

Procedure: Gastric ultrasound exam

Behavioral: Interview questionnaire

Trauma - obeyed fasting guidelines

Description:

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Treatment:

Procedure: Gastric ultrasound exam

Behavioral: Interview questionnaire

Trauma - did not obey fasting guidelines

Description:

Scheduled GI endoscopy procedure with planned oral-gastric tube placed. Complete interview questionnaire. Gastric ultrasound exam prior to upper GI endoscopy procedure.

Treatment:

Procedure: Gastric ultrasound exam

Behavioral: Interview questionnaire