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

Withdrawn

• Conditions: COVID-19; RSV Infection; Pediatric Respiratory Diseases; Asthma
• Interventions: Device: RESP™ Biosensor

• Registration Number: NCT05661422
• Lead Sponsor: Strados Labs, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Status Verified: 2023-03
• Study Start: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	RESP™ Biosensor	-

Primary Outcome Measures

Name	Time	Method
Qualification and verification of lung sounds in pediatric population using RESP Biosensor	Periodic recording over 24 hours for inpatient stay

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States