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Sponsor Hold
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This observational clinical trial is designed to confirm whether RESPâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESPâ„¢ Biosensor | Device | The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualification and verification of lung sounds in pediatric population using RESP Biosensor | Periodic recording over 24 hours for inpatient stay |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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pediatric subjects who are admitted to the hospital with respiratory disease, including exacerbation of chronic respiratory disease and infection of RSV or COVID-19
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D018357 | Respiratory Syncytial Virus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |