Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
None listed
Sponsors
Salcit Technologies Private Limited
Ministry of electronics and information technology TIDE
Eligibility
Inclusion criteria
Inclusion criteria: Male and female participants with 18 years of age and over. Patients presenting with respiratory complaints. Will have gone through the information sheet and provided informed consent.
Exclusion criteria
Exclusion criteria: Patients less than 18 years of age. Patients who are already undergoing treatment for respiratory complaints, and who are discharged from hospitals in less than 4 weeks. Patients who used inhalers 12-14 hours prior to the assessments must be excluded. (The effect of inhalers lasts for 12-14 hours). Pregnant women. Subjects in acute exacerbation/ severe breathlessness/ recent myocardial infarction or pulmonary embolism (within 4-6 weeks)/ recent eye or abdominal or brain surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effectiveness of Swaasa AI platform in detecting respiratory problems in a primary health care setting. For calculation of accuracy measures, clinical diagnosis is considered as a reference standard. The primary measures of diagnostic accuracy that will be used are sensitivity, specificity, positive and negative predictive values. 95% CIs around these parameters will be calculated using the method of clopper-pearson.Timepoint: 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of the device demonstrated based on parameters (a) Safety - Evaluate product safety in determining technical and market feasibility of the product. The safety can be evaluated based on guidelines ISO 14971. (b) Customer usage ââ?¬â?? Evaluation of usability or user-friendliness of the product or service.Timepoint: 7 months | — |
Countries
India
Contacts
Public ContactNarayana Rao Sripada
Dept of Community Medicine, AMC
Outcome results
None listed