Asthma, Bronchial Disease, Chronic Respiratory Disease, Pediatric Asthma, Respiratory Tract Diseases, Subject Presenting Wheeze
Conditions
Keywords
Wheeze, Auscultation, Wearable Medical Device
Brief summary
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.
Interventions
DEVICEAeviceMD
The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.
Sponsors
Montefiore Medical Center
Aevice Health Pte. Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is willing and/or parents/guardians are able to give informed consent for participation in the study. * Male or Female, aged ≥ 3 years. * Diagnosed with acute asthma exacerbation by an ED provider.
Exclusion criteria
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wheeze is detected by physician and AeviceMD | 60 Seconds | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician | 150 Seconds | 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. |
Countries
United States
Contacts
Primary ContactSunit P. Jariwala, Professor, M.D.
Backup ContactCarlos L. Lutz, Assistant Professor, M.D.
Outcome results
None listed