AeviceMD for Detection of Wheeze in Pediatric and Adult Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AeviceMD.
- Who it may be relevant to
- Registry conditions: Subject Presenting Wheeze, Asthma, Bronchial Disease, Respiratory Tract Diseases. Basic parameters: from 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric and Adult Populations
Overview
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
- Device AeviceMD
The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation.
Primary outcome measures
- Wheeze is detected by physician and AeviceMD [Time frame: 60 Seconds]
Secondary outcome measures (1)
- Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician [Time frame: 150 Seconds]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Montefiore Medical Center — The Bronx
Identifiers
NCT: NCT06691971 · AE_MD_002