Wearable Auscultation Device Validation in Children

N/ATerminatedNCT06112080

Strados Labs, Inc.36 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Asthma Asthma in Children Wheezing Pediatric Asthma

Interventions

RESP™ BiosensorDEVICE

The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire

PI will compare Strados RESP portal output with concurrent recordings collected via Littmann 300 Stethoscope. A questionnaire will be used to record and determine similarities and differences between RESP output and Littmann output, ultimately validating the intended use. Spectrographic data and audio recordings obtained via auscultation will be collected respectively by the RESP device and a separate recording stethoscope (Littman CORE Digital Stethoscope) simultaneously. Demographic and clinical data will be collected and stored in REDcap.

Time frame: 12 months

Secondary Outcomes

Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers

Assess the tolerability and usability of the Strados device by patients and caregivers utilizing the System Usability Scale will be used to evaluate subjects and caregivers attitudes towards the use and tolerance of the device. The System Usability Scale is a validated tool for evaluation of the usability and tolerability of a device or system by users. Then, subjects and caregivers will engage in a recorded interview using talk-aloud feedback. Recorded data will be transcribed and evaluated through quality analysis

Time frame: 12 months

Data from ClinicalTrials.gov

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