Using AI to improve lung exams for patients with acute respiratory failure
Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)
This study tests if using an AI tool with a stethoscope can help doctors better diagnose lung issues in patients with acute respiratory failure compared to standard ultrasound exams.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT05144633 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls patients at the University of Louisville's Emergency Department who are experiencing acute respiratory failure. Participants will undergo standard pulmonary point-of-care ultrasound (POCUS) and AI-assisted lung auscultation using an Eko CORE stethoscope to evaluate the effectiveness of the AI tool in diagnosing their condition. The study aims to compare the accuracy of these two diagnostic methods by analyzing the final discharge diagnosis as the ground truth. Both examinations will be performed by the same examiner, ensuring consistency in the assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older presenting with new onset shortness of breath and an increasing need for oxygen therapy.
Not a fit: Patients with trauma or pneumothorax as the cause of their acute respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing acute respiratory failure, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for diagnostic purposes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Rodrigo Cavallazzi, MD — University of Louisville
- Study coordinator: Andrea M Reyes Vega, M.D.
- Email: a0reye02@louisville.edu
- Phone: 5028528884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.