Analysis of Lung Sounds Collected by RESP Biosensor to Support Decision Making in Monitored Hospitalized Pediatric Patients

NCT ID: NCT05661422

Last Updated: 2023-03-16

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-12-31

Brief Summary

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This observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.

Detailed Description

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Conditions

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Pediatric Respiratory Diseases Asthma RSV Infection COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

RESP™ Biosensor

Intervention Type DEVICE

The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.

Interventions

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RESP™ Biosensor

The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.

Intervention Type DEVICE

Other Intervention Names

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RESP

Eligibility Criteria

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Inclusion Criteria

1. Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVID
2. Hospitalization projected for at least 24 hours after device placement
3. Patient and parent/guardian able and willing to provide informed consent/assent.

Exclusion Criteria

1. Patient and parent/guardian unable or unwilling to provide informed consent
2. Patient expected to undergo prolonged invasive radiology procedure(s)
3. Plan for discharge within 24 hours
4. Patient expected to undergo major thoracic surgery
5. History of adverse reaction or allergy to TegaDerm ® or similar product
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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Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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SL-MHUMC01

Identifier Type: -

Identifier Source: org_study_id

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