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 countryMarch 2023

ConditionsPediatric Respiratory Diseases Asthma RSV Infection COVID-19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pediatric Respiratory Diseases
Sponsor: Strados Labs, Inc.
Locations: 1
Primary Endpoint: Qualification and verification of lung sounds in pediatric population using RESP Biosensor
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 2023

End Date

December 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Strados Labs, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)