Point of Care Ultrasound for the Detection of Esophageal Food Bolus

NCT06507670 | Recruiting

• 1 other identifier: 2207289
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Foreign Body; Esophageal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies

  Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)

• Number/proportion of subjects requiring endoscopic intervention

  Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)

Study Arms (2)

Esophageal foreign body/impaction (suspected)

Diagnostic Test: Point of care ultrasound

Control (No symptoms of esophageal foreign body/impaction)

Diagnostic Test: Point of care ultrasound

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

Control (No symptoms of esophageal foreign body/impaction); Esophageal foreign body/impaction (suspected)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years
• Signs and symptoms of esophageal food bolus or foreign body

You may not qualify if:

• Prior esophageal surgery
• History of head/neck cancer
• Incarcerated individuals
• Individuals unable to provide consent
• Clinical instability or airway compromise
• Eligibility (CONTROLS)
• Age ≥18 years
• NO signs or symptoms of esophageal food bolus or foreign body
• Age/Sex match to previously enrolled case subject
• Prior esophageal surgery/dilation/pathology
• History of head/neck cancer
• Incarcerated individuals
• Individuals unable to provide consent
• Clinical instability or airway compromise
• Presentation involving any of the following symptoms:

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

WellSpan Health York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Kristen Oliff

CONTACT

717-851-5075; koliff@wellspan.org

Brent Becker, MD

CONTACT

717-851-4819; bbecker2@wellspan.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director - Department of Emergency Medicine

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 18, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)