Clinical trial NCT05144633: Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)
Official title: Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Eko Devices, Inc.
First posted: 2021-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Measure the accuracy of POCUS for the diagnosis of acute respiratory failure
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: Agreement between POCUS and Eko CORE
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Rodrigo Cavallazzi, MD
role: PRINCIPAL_INVESTIGATOR
References: