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.
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.
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.
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
Cohort
Prospective
AeviceMD
DeviceThe AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.
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.
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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Aevice Health Pte. Ltd.
Lead sponsor
Montefiore Medical Center
Collaborator
