Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: AiSteth GTX: AiSteth GTX is an Ai-enabled smart stethoscope that is intended to be used as a part of a physical assessment of a patient by healthcare professionals for screening and dia
Sponsors
Ai Health Highway India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female subjects belonging to the pediatric less than 18 years or adult 18 years and above population. 2 Provide informed consent for study participation. 3 Provide consent for recording lung and heart sounds using the AiSteth GTX. For Spirometry Subgroup if doctors suggest Participants must meet all of the following criteria to be eligible for the spirometry assessment: 1 Age 18 years and above adult population only. 2 Provide written informed consent for participation in the spirometry arm of the study. 3 Exhibit abnormal lung auscultation findings (e.g., wheeze, crackles) detected using the standard auscultation and AiSteth GTX. 4 Be clinically stable and able to perform reproducible spirometry according to standard guidelines.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if any of the following apply: 1 Belong to the neonatal population. 2 Decline to provide informed consent for study participation. 3 Are deemed medically unsuitable for participation by the PI. 4 Have a pacemaker implanted. For Spirometry Subgroup Participants will be excluded from the spirometry component of the study if any of the following apply: 1 Age less than 18 years. 2 Decline or are unable to provide informed consent for spirometry. 3 Have medical contraindications to spirometry (e.g., recent thoracic, abdominal, or eye surgery; active hemoptysis; recent pneumothorax). 4 Are medically unstable (e.g., in respiratory distress, hemodynamically unstable) as assessed by the principal investigator or study team. 5 Have cognitive, neuromuscular, or physical limitations precluding proper performance of spirometry. 6 Have a pacemaker or other implanted cardiac device, if considered a contraindication by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity,Specificity & F1 scores for detecting clinically significant adventitious lung sounds (wheeze, crackles, rhonchi fine, coarse using AiSteth Lung Sound Analysis Platform s (AsLAP) algorithmsTimepoint: There is no follow-up visit required for this study. All assessments will be conducted during the initial visit. The study will not involve any follow-up visits as it is focused on a single set of observations during the clinical visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity and Specificity of AiSteth Lung Sound Analysis Platform s (AsLAP) 2. Coefficient correlation performance of the AsLAP 3. Identifying Asthma, COPD, Pneumonia & TuberculosisTimepoint: There is no follow-up visit required for this study. All assessments will be conducted during the initial visit. The study will not involve any follow-up visits as it is focused on a single set of observations during the clinical visit. | — |
Countries
India
Contacts
Public ContactDr Guruprasad Antin
Jawaharlal Nehru Medical College (JNMC)
Outcome results
None listed