Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT05144633
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2021-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001314', 'term': 'Auscultation'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2021-08-01', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the accuracy of POCUS for the diagnosis of acute respiratory failure', 'timeFrame': '2 years', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Agreement between POCUS and Eko CORE', 'timeFrame': '2 years', 'description': 'We will measure Kappa statistic.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nUpon 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.\n\nBoth the POCUS and the EkoAI exam will be analysed by an investigator blinded to the final diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18years and older, presenting to the Emergency Department in acute respiratory failure.\n\nThese 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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years or older presenting to the ED or admitted to the hospital within 12 hours of enrollment\n* Acute respiratory failure defined as new onset shortness of breath initiated within the last 7 days, and new or increasing need for oxygen therapy\n* The patient or patient's legal health care proxy consents to participation\n\nExclusion Criteria:\n\nUnwillingness to consent\n\n* Patients with trauma as the cause of ARF\n* Patients with pneumothorax as the cause of ARF\n* Inability to perform pulmonary POCUS or lung auscultation (e.g. dressing on the chest)\n* Unwilling or unable to complete the minimum of 12 lung sound stethoscope recordings."}, 'identificationModule': {'nctId': 'NCT05144633', 'acronym': 'BEA-BEST', 'briefTitle': 'Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)', 'orgStudyIdInfo': {'id': '21.0389'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Respiratory failure', 'description': 'Patients presenting to the Emergency Department in acute respiratory failure. These patients may or may not have a diagnosis of chronic lung disease.', 'interventionNames': ['Device: Auscultation']}], 'interventions': [{'name': 'Auscultation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Acute Respiratory failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rodrigo Cavallazzi, MD', 'role': 'CONTACT', 'email': 'r0cava01@louisville.edu', 'phone': '5028525841'}, {'name': 'Andrea Reyes, MD', 'role': 'CONTACT', 'email': 'andrea.reyesvega@louisville.edu', 'phone': '5028528884'}], 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'centralContacts': [{'name': 'Andrea M Reyes Vega, M.D.', 'role': 'CONTACT', 'email': 'a0reye02@louisville.edu', 'phone': '5028528884'}, {'name': 'Rodrigo Cavallazzi, M.D.', 'role': 'CONTACT', 'email': 'rodrigo.cavallazzi@louisville.edu'}], 'overallOfficials': [{'name': 'Rodrigo Cavallazzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eko Devices, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor of Medicine', 'investigatorFullName': 'Rodrigo Cavallazzi', 'investigatorAffiliation': 'University of Louisville'}}}}