NCT05661422

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Strados Labs, Inc. · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Respiratory Diseases
• Asthma
• RSV Infection
• COVID-19

Interventions

Type	Name	Description
DEVICE	RESP™ Biosensor	The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-12-22
• Last updated: 2023-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study