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

Acute Respiratory Failure Clinical Trial

— BEA-BEST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05144633
• Other study ID #: 21.0389
• Status: Recruiting
• Start date: September 9, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: University of Louisville
• Contact: Andrea M Reyes Vega, M.D.
• Phone: 5028528884
• Email: a0reye02[@]louisville.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Eko Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Agreement between POCUS and Eko CORE	We will measure Kappa statistic.	2 years