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RecruitingNCT06507670

Point of Care Ultrasound for the Detection of Esophageal Food Bolus

Status
Recruiting
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
WellSpan Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPoint of care ultrasoundPoint 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

Timeline

Start date
2024-07-01
Primary completion
2026-06-30
Completion
2027-01-01
First posted
2024-07-18
Last updated
2024-07-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06507670. Inclusion in this directory is not an endorsement.