Point of Care Ultrasound for the Detection of Esophageal Food Bolus

NCT ID: NCT06507670

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Foreign Body Esophageal Obstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Esophageal foreign body/impaction (suspected)

Point of care ultrasound

Intervention Type 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

Control (No symptoms of esophageal foreign body/impaction)

Point of care ultrasound

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Point of care ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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

Eligibility (CONTROLS)


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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

WellSpan Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brent Becker

Research Director - Department of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WellSpan Health York Hospital

York, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kristen Oliff

Role: CONTACT

717-851-5075

Brent Becker, MD

Role: CONTACT

717-851-4819

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kristen Oliff

Role: primary

717-851-5075

Brent Becker, MD

Role: backup

717-851-4819

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2207289

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Transgastrostomal Endoscopies
NCT04309825 WITHDRAWN NA