Clinical trial NCT06507670: Point of Care Ultrasound for the Detection of Esophageal Food Bolus
Official title: Point of Care Ultrasound for the Detection of Esophageal Food Bolus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Foreign Body
Esophageal Obstruction
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Eligibility (CASES)

* Inclusion criteria:

  1. Age ≥18 years
  2. Signs and symptoms of esophageal food bolus or foreign body
* Exclusion criteria:

  1. Prior esophageal surgery
  2. History of head/neck cancer
  3. Incarcerated individuals
  4. Individuals unable to provide consent
  5. Clinical instability or airway compromise

Eligibility (CONTROLS)

* Inclusion criteria:

  1. Age ≥18 years
  2. NO signs or symptoms of esophageal food bolus or foreign body
  3. Age/Sex match to previously enrolled case subject
* Exclusion criteria:

  1. Prior esophageal surgery/dilation/pathology
  2. History of head/neck cancer
  3. Incarcerated individuals
  4. Individuals unable to provide consent
  5. Clinical instability or airway compromise
  6. Presentation involving any of the following symptoms:
* Nausea/vomiting
* Diarrhea
* Abdominal pain
* Chest pain
* Shortness of breath
* Dysphagia/odynophagia
* Cough

Primary outcomes:
measure: Presence or absence of esophageal foreign body/food impaction
timeFrame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Secondary outcomes:
measure: Number/proportion of subjects experiencing resolution of symptoms with standard medical therapies
timeFrame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
measure: Number/proportion of subjects requiring endoscopic intervention
timeFrame: Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpan Health York Hospital
state: Pennsylvania
Study officials:
References: