Actively Recruiting
Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST) Observational Study to Evaluate AI-Assisted Lung Exam with Pulmonary POCUS for Acute Respiratory Failure Diagnosis
Led by University of Louisville · Updated on 2025-01-20
100
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
E
Eko Devices, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding Eko AI-assisted lung auscultation to the standard Pulmonary Point-of-Care Ultrasound (POCUS) can improve the diagnosis of acute respiratory failure in patients. This observational study involves patients at the University of Louisville Emergency Department who present with acute respiratory failure, which is characterized by new shortness of breath and increased oxygen needs within the past week. Once enrolled and consented, participants will undergo both the standard POCUS exam and an AI-assisted lung auscultation exam using the Eko CORE stethoscope. These exams can be performed immediately and in any order by the same examiner, wherever the patient is located in the hospital. Both exams will be analyzed by investigators who do not know the patient's final diagnosis to ensure unbiased results. During the study, researchers will collect data to measure the accuracy of POCUS alone, POCUS combined with Eko AI-assisted auscultation, and agreement between the two methods in diagnosing acute respiratory failure. The final hospital discharge diagnosis will serve as the reference standard. The study will follow participants for up to two years to assess these outcomes.
CONDITIONS
Official Title
Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- New or increasing need for oxygen therapy
- The patient or patient's legal health care proxy consents to participation
You will not qualify if you...
- Unwillingness to consent
- Patients with trauma as the cause of acute respiratory failure
- Patients with pneumothorax as the cause of acute respiratory failure
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
A
Andrea M Reyes Vega, M.D.
R
Rodrigo Cavallazzi, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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