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NCT Number: NCT06507670

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.

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Key information

Conditions

Esophageal Foreign Body Airway Obstruction Esophageal Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligibility (CASES)

  • Inclusion criteria:
  • Age ≥18 years
  • Signs and symptoms of esophageal food bolus or foreign body
  • Exclusion criteria:
  • Prior esophageal surgery
  • History of head/neck cancer
  • Incarcerated individuals
  • Individuals unable to provide consent
  • Clinical instability or airway compromise

Eligibility (CONTROLS)

  • Inclusion criteria:
  • Age ≥18 years
  • NO signs or symptoms of esophageal food bolus or foreign body
  • Age/Sex match to previously enrolled case subject
  • Exclusion criteria:
  • 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:
  • Nausea/vomiting
  • Diarrhea
  • Abdominal pain
  • Chest pain
  • Shortness of breath
  • Dysphagia/odynophagia
  • Cough

Treatment and study plan

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

Primary outcomes

  1. 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)

    Presence of absence of esophageal foreign body/food impaction on esophagogastroduodenoscopy

Secondary outcomes

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

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

    Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies, including glucagon and carbonated beverages

  2. Number/proportion of subjects requiring endoscopic intervention

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

    Number/proportion of subjects needing interventional procedures during esophagogastroduodenoscopy due to esophageal symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Brent Becker, MD

CONTACT

[email protected]

717-851-4819

Kristen Oliff

CONTACT

[email protected]

717-851-5075

Sponsors and collaborators

Lead sponsor

WellSpan Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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