NCT05144633

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-09-09
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2021-12-03
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study