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

NCT05144633 | Recruiting FDA Device

• 1 other identifier: 21.0389
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• Measure the accuracy of POCUS for the diagnosis of acute respiratory failure

  POCUS consists of an ultrasound examination at bedside. We will perform lung ultrasound and the pattern of lung ultrasound will be used to diagnose the cause of acute respiratory failure. The reference standard will be the the final diagnosis by the clinician. The accuracy measures will include sensitivity, specificity, positive predictive value, and negative predictive value.

  2 years

• Measure the accuracy of POCUS plus Eko for the diagnosis of acute respiratory failure. AI-assisted lung auscultation for the diagnosis of the case of acute respiratory failure.

  POCUS was described above. Ekos consists of a digital stethoscope. The lung auscultation pattern will be used to determine the cause of acute respiratory failure. POCUS and Eko will be integrated to establish the cause of acute respiratory failure. The reference standard will be the final diagnosis by the clinician.

  2 years

• Agreement between POCUS and Eko CORE

  We will measure Kappa statistic.

  2 years

Study Arms (1)

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.

Device: Auscultation

Interventions

Auscultation 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.

Acute Respiratory failure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18years and older, presenting to the Emergency Department in acute respiratory failure. These patients may or may not have a diagnosis of chronic lung disease. It may be necessary to enroll more than 100 subjects in order to achieve 100 completed datasets.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• Eko Devices, Inc.: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Interventions

Auscultation

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rodrigo Cavallazzi, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea M Reyes Vega, M.D.

CONTACT

5028528884; a0reye02@louisville.edu

Rodrigo Cavallazzi, M.D.

CONTACT

rodrigo.cavallazzi@louisville.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor of Medicine

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: December 3, 2021
• Study Start: September 9, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 20, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)