Gastric Ultrasound for Estimation of the Aspiration Risk Study

Respiratory Aspiration of Gastric Contents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03310528
• Other study ID #: IRB201602234
• Secondary ID: OCR18887
• Status: Recruiting
• Start date: March 27, 2018
• Est. completion date: July 14, 2026

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Amanda Slater
• Phone: 352-273-8952
• Email: aslater[@]anest.ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 14, 2026
• Est. primary completion date: July 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Aspiration of Gastric Contents

Intervention

Behavioral:
• Interview questionnaire
Complete interview questionnaire regarding the composition and timing of their most recent food intake.

Procedure:
• Gastric ultrasound exam
Gastric ultrasound exam prior to upper GI endoscopy procedure.

Locations

Country	Name	City	State
United States	United States, Florida UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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