Using gastric ultrasound to assess aspiration risk before surgery
Gastric Ultrasound for Estimation of the Aspiration Risk in High Aspiration-risk Surgical Patient Populations
This study tests if using ultrasound to check for leftover food in the stomach can help doctors understand the risk of aspiration in patients before surgery, especially for those who might not have fasted properly.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT03310528 on ClinicalTrials.gov |
What this trial studies
This research examines the effectiveness of current anesthesia guidelines regarding pre-surgical fasting in patients likely to have delayed gastric emptying. It utilizes ultrasound to evaluate residual gastric contents in patients undergoing upper GI endoscopy, both those who have adhered to fasting guidelines and those who have not. The goal is to better understand aspiration risk in these populations and determine if current fasting guidelines are appropriate.
Who should consider this trial
Good fit: Ideal candidates are adults presenting for upper GI endoscopy procedures who are expected to have an oral-gastric tube placed.
Not a fit: Patients who are unwilling to undergo an ultrasound exam or those for whom oral-gastric tube placement is contraindicated will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety protocols for patients undergoing surgery, reducing the risk of aspiration.
How similar studies have performed: While the approach of using gastric ultrasound is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- United States, Florida UF Health — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Cameron Smith, MD, PhD — University of Florida
- Study coordinator: Amanda Slater
- Email: aslater@anest.ufl.edu
- Phone: 352-273-8952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.