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Recruiting NCT06507670

Point of Care Ultrasound for the Detection of Esophageal Food Bolus

— Observational Esophageal Foreign Body Esophageal Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Point of care ultrasound.
Who it may be relevant to
Registry conditions: Esophageal Foreign Body, Esophageal Obstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • 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 requiring endoscopic intervention [Time frame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • WellSpan Health York Hospital — York

Identifiers

NCT: NCT06507670 · 2207289

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗