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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05661422
• Other study ID #: SL-MHUMC01
• Status: Withdrawn
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Strados Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COVID-19
• Pediatric Respiratory Diseases
• Respiration Disorders
• Respiratory Sounds
• Respiratory Syncytial Virus Infections
• Respiratory Tract Diseases
• RSV Infection

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Health University Medical Center	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Strados Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualification and verification of lung sounds in pediatric population using RESP Biosensor		Periodic recording over 24 hours for inpatient stay
Secondary	Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families		Periodic recording over 24 hours for inpatient stay
Secondary	Limitations such as age in pediatric patients		Periodic recording over 24 hours for inpatient stay