Clinical trial NCT03310528: Gastric Ultrasound for Estimation of the Aspiration Risk Study
Official title: Gastric Ultrasound for Estimation of the Aspiration Risk in High Aspiration-risk Surgical Patient Populations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Aspiration of Gastric Contents
Keywords: Aspiration risk
GI Endoscopy
Fasting guidelines
Delayed gastric emptying
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for upper GI endoscopy and/or endoscopic retrograde cholangiopancreatogram (ERCP), expected to have an oral-gastric tube placed as part of scheduled procedure.

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.

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

Primary outcomes:
measure: Changes in gastric content volume between the four groups assessed by ultrasound examination
timeFrame: Up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: United States, Florida UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Cameron Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: