Point of Care Ultrasound for the Detection of Esophageal Food Bolus
Part of paid clinical trials in York, Pennsylvania.
- Sponsor
- WellSpan Health
- Study ID
- NCT06507670
- Status
- Recruiting
Conditions
- Esophageal Foreign Body
- Esophageal Obstruction
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Point of care ultrasound — DIAGNOSTIC_TESTPoint of care medical ultrasound machines will be used to sonographically visualize the esophagus and following sonographic data will be collected: * Presence/absence of suspected foreign body * Sonographic esophageal measurements (diameters, area) * Other relevant secondary sonographic findings
Study Details
This will be a prospective, observational, case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. Point of care ultrasound (POCUS) will then be performed by a trained emergency physician to collect ultrasound data, including the presence or absence of direct visualization food bolus/foreign body, as well as secondary markers of dilatation, such as maximal esophageal area. Investigators will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements. Patients will otherwise receive medical treatment per standard of care. Subsequent interventions will also be documented, including glucagon, carbonated beverages, and esophagogastroduodenoscopy (EGD). If patients remain in the ED and improve without need for EGD they will undergo repeat ultrasound. Chart review at 1 month will be performed to establish results of EGD including improvement, recurrence, or presence of pathologic abnormalities. The investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive EGD management.
Key Dates
- Start date
- Jul 1, 2024
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Mar 1, 2027
Study Design
- Enrollment
- 30 participants (estimated)
Arms
- Arm: Esophageal foreign body/impaction (suspected)
- Arm: Control (No symptoms of esophageal foreign body/impaction)
Primary Outcome Measure
Presence or absence of esophageal foreign body/food impaction [ Time Frame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge) ]
Central Contacts
- Kristen Oliff717-851-5075
- Brent Becker, MD717-851-4819
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| WellSpan Health York Hospital | York | Pennsylvania | 17403 |