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Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05661422

Enrollment

Registered

2022-12-22

Start date

2023-03-31

Completion date

2023-12-31

Last updated

2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICERESP™ Biosensor

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 17 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026