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Not Yet Recruiting NCT05661422

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

Conditions: Pediatric Respiratory Diseases, Asthma, RSV Infection, COVID-19

Sex: All
Ages: 4 Years – 17 Years
Enrollment: 20
Sponsor: Strados Labs, Inc.

Location: United States

Summary

This observational clinical trial is designed to confirm whether RESP 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.

Eligibility Criteria

Inclusion Criteria:Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVIDHospitalization projected for at least 24 hours after device placementPatient and parent/guardian able and willing to provide informed consent/assent.Exclusion Criteria:Patient and parent/guardian unable or unwilling to provide informed consentPatient expected to undergo prolonged invasive radiology procedure(s)Plan for discharge within 24 hoursPatient expected to undergo major thoracic surgeryHistory of adverse reaction or allergy to TegaDerm ® or similar product

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05661422). StuddyBuddy aggregates publicly available trial information.