Recruiting

Blue Protocol & Eko AI

Sponsor:

University of Louisville

Code:

NCT05144633

Conditions

Acute Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Auscultation

Study Details

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

Study ID

NCT05144633

Start date

Sep 9, 2021

Status verified date

Jun, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Measure the accuracy of POCUS for the diagnosis of acute respiratory failure [ Time Frame: 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. [ Time Frame: 2 years ]
  • Agreement between POCUS and Eko CORE [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Andrea M Reyes Vega, M.D.

5028528884a0reye02@louisville.edu

Rodrigo Cavallazzi, M.D.

rodrigo.cavallazzi@louisville.edu

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Rodrigo Cavallazzi, MD

5028525841r0cava01@louisville.edu

Andrea Reyes, MD

5028528884andrea.reyesvega@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

Jan 20, 2025

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-01-20.