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 |
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Participants |
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Recruiting Locations
More Details
- NCT ID
- NCT05661422
- Status
- Withdrawn
- Sponsor
- Strados Labs, Inc.