Point of Care Ultrasound for the Detection of Esophageal Food Bolus

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Obstruction; Esophageal Foreign Body
• Intervention / Treatment: Diagnostic test: Point of care ultrasound

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Brent Becker, MD; Phone Number: 717-851-4819; Email: bbecker2@wellspan.org
• Study Contact Backup: Name: Kristen Oliff; Phone Number: 717-851-5075; Email: koliff@wellspan.org

Study Locations

• United States
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Recruiting
      • Wellspan Health York Hospital
      • Contact: Brent Becker, MD; Phone Number: 717-851-4819; Email: bbecker2@wellspan.org
      • Contact: Kristen Oliff; Phone Number: 717-851-5075; Email: koliff@wellspan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This will be a 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. We will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements.

Description

Eligibility (CASES)

• Inclusion criteria:

  1. Age ≥18 years
  2. Signs and symptoms of esophageal food bolus or foreign body

• Exclusion criteria:

  1. Prior esophageal surgery
  2. History of head/neck cancer
  3. Incarcerated individuals
  4. Individuals unable to provide consent
  5. Clinical instability or airway compromise

Eligibility (CONTROLS)

• Inclusion criteria:

  1. Age ≥18 years
  2. NO signs or symptoms of esophageal food bolus or foreign body
  3. Age/Sex match to previously enrolled case subject

• Exclusion criteria:

  1. Prior esophageal surgery/dilation/pathology
  2. History of head/neck cancer
  3. Incarcerated individuals
  4. Individuals unable to provide consent
  5. Clinical instability or airway compromise
  6. Presentation involving any of the following symptoms:
• Nausea/vomiting
• Diarrhea
• Abdominal pain
• Chest pain
• Shortness of breath
• Dysphagia/odynophagia
• Cough

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Esophageal foreign body/impaction (suspected)	Diagnostic test: Point of care ultrasound; 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
Control (No symptoms of esophageal foreign body/impaction)	Diagnostic test: Point of care ultrasound; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of esophageal foreign body/food impaction	Presence of absence of esophageal foreign body/food impaction on esophagogastroduodenoscopy	Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies	Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies, including glucagon and carbonated beverages	Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Number/proportion of subjects requiring endoscopic intervention	Number/proportion of subjects needing interventional procedures during esophagogastroduodenoscopy due to esophageal symptoms	Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)

Collaborators and Investigators

• Sponsor: WellSpan Health

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies
• Other Study ID Numbers: 2207289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No