Point of Care Ultrasound for the Detection of Esophageal Food Bolus

Recruiting

• Conditions: Esophageal Obstruction; Esophageal Foreign Body
• Interventions: Diagnostic Test: Point of care ultrasound

• Registration Number: NCT06507670
• Lead Sponsor: WellSpan Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2026-06-30
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophageal foreign body/impaction (suspected)	Point of care ultrasound	-
Control (No symptoms of esophageal foreign body/impaction)	Point of care ultrasound	-

Primary Outcome Measures

Name	Time	Method
Presence or absence of esophageal foreign body/food impaction	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

Secondary Outcome Measures

Name	Time	Method
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 experiencing resolution of symptoms with standard medical therapies, including glucagon and carbonated beverages
Number/proportion of subjects requiring endoscopic intervention	Within 48 hours of index visit (Emergency department arrival to emergency department or hospital discharge)	Number/proportion of subjects needing interventional procedures during esophagogastroduodenoscopy due to esophageal symptoms

Trial Locations

Locations (1)

WellSpan Health York Hospital; 🇺🇸 York, Pennsylvania, United States