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Clinical Trials/NCT03310528
NCT03310528
Active, not recruiting
Not Applicable

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

University of Florida1 site in 1 country200 target enrollmentMarch 27, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Aspiration of Gastric Contents
Sponsor
University of Florida
Enrollment
200
Locations
1
Primary Endpoint
Changes in gastric content volume between the four groups assessed by ultrasound examination
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 27, 2018
End Date
July 14, 2026
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in gastric content volume between the four groups assessed by ultrasound examination

Time Frame: 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.

Study Sites (1)

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