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RECRUITINGNCT05144633

Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)

This is an observational study that will be enrolling University of Louisville patients who present to the Emergency Department in Acute Respiratory Failure. This study will be to determine if the add...

Lead sponsor: University of Louisville•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Andrea M Reyes Vega, M.D.

CONTACT

5028528884 a0reye02@louisville.edu

Rodrigo Cavallazzi, M.D.

CONTACT

rodrigo.cavallazzi@louisville.edu

Sponsors

Lead Sponsor

University of Louisville

Collaborators

Eko Devices, Inc.

Once identified and consented, the subject will undergo both POCUS and AI-assisted lung auscultation using an Eko CORE stethoscope. The POCUS protocol described here is the standard of care for patients who present in acute respiratory failure to the Emergency Room and both groups will receive this standardized care during the study. Upon hospital discharge, the final discharge diagnosis will be used as the ground truth for assessing the accuracy of the POCUS protocol. The POCUS exam and the EkoAI exam may be performed wherever the subject is located in the hospital when first enrolled in the study. If possible, both exams should be performed immediately, in either order. They will be performed by the same examiner. Both the POCUS and the EkoAI exam will be analysed by an investigator blinded to the final diagnosis.

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Adults aged 18 years or older presenting to the ED or admitted to the hospital within 12 hours of enrollment
•Acute respiratory failure defined as new onset shortness of breath initiated within the last 7 days, and new or increasing need for oxygen therapy
•The patient or patient's legal health care proxy consents to participation

Exclusion Criteria

•Unwillingness to consent
•Patients with trauma as the cause of ARF
•Patients with pneumothorax as the cause of ARF
•Inability to perform pulmonary POCUS or lung auscultation (e.g. dressing on the chest)
•Unwilling or unable to complete the minimum of 12 lung sound stethoscope recordings.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 20, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment100

Start dateSep 2021

Last updatedJan 20, 2025

Condition

Acute Respiratory Failure

Locations shown

University of Louisville

Louisville, Kentucky

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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