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

NCT05661422 | Withdrawn FDA Device

• 1 other identifier: SL-MHUMC01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Qualification and verification of lung sounds in pediatric population using RESP Biosensor

  Periodic recording over 24 hours for inpatient stay

Secondary Outcomes (2)

• Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families

  Periodic recording over 24 hours for inpatient stay

• Limitations such as age in pediatric patients

  Periodic recording over 24 hours for inpatient stay

Study Arms (1)

Participants

Device: RESP™ Biosensor

Interventions

RESP™ Biosensor DEVICE

The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.

Also known as: RESP

Participants

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric subjects who are admitted to the hospital with respiratory disease, including exacerbation of chronic respiratory disease and infection of RSV or COVID-19

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Strados Labs, Inc.: lead

Study Sites (1)

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

MeSH Terms

Conditions

Asthma; Respiratory Syncytial Virus Infections; COVID-19

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (1)