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| Name | Class |
|---|---|
| Montefiore Medical Center | OTHER |
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Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with acute asthma exacerbation | Patients diagnosed with acute asthma exacerbation |
| |
| Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis | Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AeviceMD | Device | The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wheeze is detected by physician and AeviceMD | Primary endpoint of wheeze will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation. AeviceMD will perform wheeze analysis on each 5 sec of recording. | 60 Seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician | Secondary endpoint of normal, abnormal and absent breath breath sounds will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation - i.e. bronchovesicular, crackles. Normal, abnormal and absent breath sounds will be annotated in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the independent physician during remote auscultation - i.e. bronchovesicular, crackles. |
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Inclusion Criteria:
Exclusion Criteria:
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Study will include 160 Subjects (80 Pediatrics and 80 Adult Subjects) who are presenting with wheeze in the emergency department, and outpatient and inpatient settings
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunit P. Jariwala, Professor, M.D. | Contact | 718-920-6089 | sjariwal@montefiore.org | |
| Carlos L. Lutz, Assistant Professor, M.D. | Contact | 718-920-6626 | clutz@montefiore.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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|
| 150 Seconds |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |