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_TEST
    Point 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

Locations (1)

FacilityCityStateZIPSite coordinators
WellSpan Health York HospitalYorkPennsylvania17403
Kristen Oliff
717-851-5075
Brent Becker, MD
717-851-4819

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