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Wearable Auscultation Device Validation in Children

Recruiting
4 - 17 years of age
Both
Phase N/A

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Overview

This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.

Eligibility

Inclusion Criteria:

  • Any child aged 4-17 years of age
  • Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
  • Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
    • Admitted for a non-respiratory complaint
    • Normal breath sounds on screening examination
  • Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
    • Admitted for pathologic process that may lead to wheezing (e.g., asthma)
    • Presence of wheeze on screening examination

Exclusion Criteria:

  • Children less than age 4, adults (age 18 and above)
  • Patients in the ambulatory setting
  • Unable to provide consent
  • Intubated patients
  • Unstable disease posing a threat to life
  • Adhesive allergy

Study details

Asthma, Asthma in Children, Wheezing, Pediatric Asthma

NCT06112080

Strados Labs, Inc.

26 January 2024

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