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

March 14, 2023 updated by: Strados Labs, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
Device: RESP™ Biosensor
The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.
Other Names:
  • RESP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Limitations such as age in pediatric patients
Time Frame: Periodic recording over 24 hours for inpatient stay
Periodic recording over 24 hours for inpatient stay
Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families
Time Frame: Periodic recording over 24 hours for inpatient stay
Periodic recording over 24 hours for inpatient stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Strados Labs, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-MHUMC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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