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临床试验/NCT06507670
NCT06507670招募中不适用

Point of Care Ultrasound for the Detection of Esophageal Food Bolus

WellSpan Health2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Presence or absence of esophageal foreign body/food impaction

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility (CASES)
  • Inclusion criteria:
  • Age ≥18 years
  • Signs and symptoms of esophageal food bolus or foreign body

排除标准

  • 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
  • Abdominal pain
  • Chest pain
  • Shortness of breath
  • Dysphagia/odynophagia

结局指标

主要结局

Presence or absence of esophageal foreign body/food impaction

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brent Becker

Research Director - Department of Emergency Medicine

WellSpan Health

研究点 (2)

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