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A clinical validation of respiratory medical device and its correlation with clinical tests and diagnosis

Respiratory sound analysis and correlation with clinical tests and clinical diagnosis - Salcit Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/08/015237
Enrollment
100
Registered
2018-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J988- Other specified respiratory disorders

Interventions

None listed

Sponsors

SALCIT TECHNOLOGIES PRIVATE LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written signed and dated informed consent (patient or LAR) 2. Either gender with age 18 years and above. 3. Subjects suffering with CRDâ??s, Pulmonary Tuberculosis, CHF and Pulmonary Fibrosis.

Exclusion criteria

Exclusion criteria: 1. Subjects who require ventilation, flow of oxygen must be excluded from the study.

Design outcomes

Primary

MeasureTime frame
1. Test the hypothesis that the sound characteristics differ for various CRDs. Sound characteristics can be used in determining severity of inflammation. 2.Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis.Timepoint: For each subject minimum of 5 records are required for in-patients. 2 records on the first and second day of admission. 2 records during course of treatment (after first or second day and prior to discharge) 1 record during discharge (or during stable state) For each outpatient a minimum of 2 records will be attempted.

Secondary

MeasureTime frame
Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis.Timepoint: For each subject minimum of 5 records are required for in-patients. 2 records on the first and second day of admission. 2 records during course of treatment (after first or second day and prior to discharge) 1 record during discharge (or during stable state) For each outpatient a minimum of 2 records will be attempted.

Countries

India

Contacts

Public ContactNarayana Rao Sripada

SALCIT TECHNOLOGIES PRIVATE LIMITED

svnnrao@gmail.com919945399533

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026