Data Collection Using Eko Digital Devices in a Clinical Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eko digital stethoscopes.
- Who it may be relevant to
- Registry conditions: Lung Diseases. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this research is to prospectively train and validate an artificial intelligence machine learning (ML) algorithm to detect the presence of adventitious lung sounds in adults. Clinicians will use the Eko CORE and/or Eko CORE 500 device(s) in real clinical settings to collect normal and abnormal lung sounds, as part of standard of care clinical practice, which will then be used to explore an ML algorithm for classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine any correspondences between the type and/or location of adventitious lung sounds and the type of pulmonary conditions as reported by clinicians.
Interventions
- Device Eko digital stethoscopes
Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to listen for and record lung sounds.
Primary outcome measures
- Primary Objective [Time frame: Through study completion, an average of 8-9 months]
Eligibility criteria
Inclusion criteria
- Suspected or diagnosed lower respiratory condition OR Presence of wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough discovered during routine auscultation
- Normal patients with no adventitious lung sounds
- Adults and pediatric patients (as available)
Exclusion criteria
- Unable to have multiple recordings taken on chest and back (e.g. compromised mobility)
- On mechanical ventilation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Nemours Children's Health — Jacksonville
- Jefferson Einstein Philadelphia Hospital — Philadelphia
Identifiers
NCT: NCT07227376 · 2022.5 V10.0