Actively Recruiting
Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST) Study Evaluating AI-Assisted Lung Auscultation in Acute Respiratory Failure
Led by University of Louisville · Updated on 2025-01-20
100
Participants Needed
1
Research Sites
N/A
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 the use of Eko AI-assisted lung auscultation combined with standard Pulmonary Point-of-Care Ultrasound (POCUS) to help diagnose acute respiratory failure in patients. This observational study involves patients at the University of Louisville who present to the Emergency Department with acute respiratory failure, aiming to see if adding AI-assisted auscultation improves diagnostic accuracy. Participants will undergo both the standard POCUS exam and the AI-assisted lung auscultation using an Eko CORE stethoscope. These exams are conducted wherever the patient is located in the hospital at the time of enrollment, ideally immediately and by the same examiner. The study compares the accuracy of POCUS alone versus POCUS plus AI-assisted auscultation by analyzing results blinded to the final discharge diagnosis. Patients will be monitored during their hospital stay, with the final discharge diagnosis serving as the reference for assessment. The study measures the accuracy of both diagnostic methods over two years and evaluates the agreement between POCUS and the Eko CORE device. Participation involves hospital-based exams and data collection related to lung sounds and ultrasound findings.
CONDITIONS
Brief 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 Emergency Department or admitted within 12 hours of enrollment
- New onset shortness of breath starting within the last 7 days
- New or increasing need for oxygen therapy
- Ability to provide consent or have a legal health care proxy consent
You will not qualify if you...
- Unwillingness to consent
- Trauma as the cause of acute respiratory failure
- Pneumothorax as the cause of acute respiratory failure
- Inability to perform pulmonary POCUS or lung auscultation (e.g., chest dressing)
- Unable or unwilling to complete at least 12 lung sound recordings with the stethoscope
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 hours from enrollment during hospital stay
Participants undergo AI-assisted lung auscultation using the Eko CORE stethoscope along with standard Pulmonary POCUS as part of routine care for acute respiratory failure.
1 visit (in-person) performed wherever the participant is located in the hospital
Duration - Up to hospital discharge
Participants are observed until hospital discharge for final diagnosis to assess the accuracy of the exams performed.
No additional visits required beyond routine hospital care
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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