A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric and Adult Populations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subject Presenting Wheeze
- Sponsor
- Aevice Health Pte. Ltd.
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Wheeze is detected by physician and AeviceMD
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Wheeze is detected by physician and AeviceMD
Time Frame: 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 Outcomes
- Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician(150 Seconds)