Point of Care Ultrasound for the Detection of Esophageal Food Bolus

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWellSpan Health

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years

Signs and symptoms of esophageal food bolus or foreign body

Disqualifiers

Prior esophageal surgery

History of head/neck cancer

Incarcerated individuals

Individuals unable to provide consent

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Esophageal foreign body/impaction (suspected)1 intervention
Group B: Control (No symptoms of esophageal foreign body/impaction)1 intervention

Trial outcomes

Primary outcomes

1

Presence or absence of esophageal foreign body/food impaction

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

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

Secondary outcomes

1

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

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

Time frame
Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)
2

Number/proportion of subjects requiring endoscopic intervention

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

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

Other outcomes

Sponsors and contacts

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