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

Strados Labs

Status: Withdrawn

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

Treatments: Device: RESP™ Biosensor

Study type: Observational

Funder types: Industry

Identifiers

NCT05661422

SL-MHUMC01

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Participants

Treatment:

Device: RESP™ Biosensor