Wearable Auscultation Device Validation in Children

NCT ID: NCT06112080

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-07

Study Completion Date

2024-06-24

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Asthma in Children Wheezing Pediatric Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Breath Sound Cohort

32 patients ages 4-10, 16 patients ages 11-17)

* Admitted for a non-respiratory complaint
* Normal breath sounds on screening examination

RESP™ Biosensor

Intervention Type DEVICE

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

Wheeze Cohort

(106 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

RESP™ Biosensor

Intervention Type DEVICE

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

Interventions

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RESP™ Biosensor

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

Intervention Type DEVICE

Other Intervention Names

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Remote Electronic Stethoscope Platform

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Strados Labs, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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SL-LC01

Identifier Type: -

Identifier Source: org_study_id

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