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Clinical Trials/NCT05661422
NCT05661422WithdrawnNot Applicable

Spectrographic and Acoustic Analysis of Lung Sounds Collected by RESP™ Biosensor to Support of Cardiorespiratory Therapeutic Decision Making in Monitored Hospitalized Pediatric Patients

Strados Labs, Inc.1 site in 1 countryStarted: March 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Qualification and verification of lung sounds in pediatric population using RESP Biosensor
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
4 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Patient and parent/guardian unable or unwilling to provide informed consent
  • •Patient expected to undergo prolonged invasive radiology procedure(s)
  • •Plan for discharge within 24 hours
  • •Patient expected to undergo major thoracic surgery
  • •History of adverse reaction or allergy to TegaDerm ® or similar product

Outcomes

Primary Outcomes

Qualification and verification of lung sounds in pediatric population using RESP Biosensor

Time Frame: Periodic recording over 24 hours for inpatient stay

Secondary Outcomes

  • Limitations such as age in pediatric patients(Periodic recording over 24 hours for inpatient stay)
  • Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families(Periodic recording over 24 hours for inpatient stay)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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