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

NCT ID: NCT05144633

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2025-04-30

Brief Summary

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 addition of Eko AI-assisted lung auscultation examination to a standard of care Pulmonary POCUS + assists with acute respiratory failure diagnosis.

Detailed Description

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.

Conditions

Acute Respiratory Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Acute Respiratory failure

Patients presenting to the Emergency Department in acute respiratory failure. These patients may or may not have a diagnosis of chronic lung disease.

Auscultation

Intervention Type: DEVICE

This study will be to determine if the addition of Eko AI-assisted lung auscultation examination to a standard of care Pulmonary POCUS + assists with acute respiratory failure diagnosis.

Interventions

Auscultation

This study will be to determine if the addition of Eko AI-assisted lung auscultation examination to a standard of care Pulmonary POCUS + assists with acute respiratory failure diagnosis.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eko Devices, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Cavallazzi

MD, Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Cavallazzi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrea M Reyes Vega, M.D.

Role: CONTACT

a0reye02@louisville.edu

5028528884

Rodrigo Cavallazzi, M.D.

Role: CONTACT

rodrigo.cavallazzi@louisville.edu

Facility Contacts

Rodrigo Cavallazzi, MD

Role: primary

r0cava01@louisville.edu

5028525841

Andrea Reyes, MD

Role: backup

andrea.reyesvega@louisville.edu

5028528884

Other Identifiers

21.0389

Identifier Type: -

Identifier Source: org_study_id