Point of Care Ultrasound for the Detection of Esophageal Food Bolus

Обзор

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Presence or absence of esophageal foreign body/food impaction [Срок оценки: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)]

Вторичные конечные точки (2)

• Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies [Срок оценки: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)]
• Number/proportion of subjects requiring endoscopic intervention [Срок оценки: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• WellSpan Health York Hospital — York

Идентификаторы

NCT: NCT06507670 · 2207289

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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