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The Principal Investigator is departing from the study site.
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This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Breath Sound Cohort | 32 patients ages 4-10, 16 patients ages 11-17)
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| Wheeze Cohort | (106 patients ages 4-10, 53 patients ages 11-17)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESP™ Biosensor | Device | The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds. |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire | PI will compare Strados RESP portal output with concurrent recordings collected via Littmann 300 Stethoscope. A questionnaire will be used to record and determine similarities and differences between RESP output and Littmann output, ultimately validating the intended use. Spectrographic data and audio recordings obtained via auscultation will be collected respectively by the RESP device and a separate recording stethoscope (Littman CORE Digital Stethoscope) simultaneously. Demographic and clinical data will be collected and stored in REDcap. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers | Assess the tolerability and usability of the Strados device by patients and caregivers utilizing the System Usability Scale will be used to evaluate subjects and caregivers attitudes towards the use and tolerance of the device. The System Usability Scale is a validated tool for evaluation of the usability and tolerability of a device or system by users. Then, subjects and caregivers will engage in a recorded interview using talk-aloud feedback. Recorded data will be transcribed and evaluated through quality analysis |
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Inclusion Criteria:
Any child aged 4-17 years of age
Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
Exclusion Criteria:
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pediatric subjects who present to Lurie Children's Hospital with or without wheezing.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 12 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |