CD2H COVID-19

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

Purpose

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

Eligibility

Eligible Ages: Between 4 Years and 17 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Participants		Device: RESP™ Biosensor The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound. Other names: RESP

Recruiting Locations

More Details

NCT ID: NCT05661422
Status: Withdrawn
Sponsor: Strados Labs, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.