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

Completed

• Conditions: Other specified respiratory disorders,

• Registration Number: CTRI/2018/08/015237
• Lead Sponsor: SALCIT TECHNOLOGIES PRIVATE LIMITED

Brief Summary

This is a validation study to analyze the data delivered by the study device and correlate with clinical tests and diagnosis. This study will analyze the respiratory sounds characteristics of the patients suffering from various chronic respiratory diseases, pulmonary tuberculosis, and congestive heart failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-09
• Study Completion: 2019-09-07
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Written signed and dated informed consent (patient or LAR) 2.
• Either gender with age 18 years and above.
• Subjects suffering with CRD’s, Pulmonary Tuberculosis, CHF and Pulmonary Fibrosis.

Exclusion Criteria

Subjects who require ventilation, flow of oxygen must be excluded from the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.
1. Test the hypothesis that the sound characteristics differ for various CRDs. Sound characteristics can be used in determining severity of inflammation.	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 Outcome Measures

Name	Time	Method
Test the hypothesis that sound characteristics have correlation with clinical test like spirometry and associated parameters, bed side lung function tests and clinical diagnosis.	For each subject minimum of 5 records are required for in-patients.

Trial Locations

Locations (1)

Apollo Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Apollo Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Sai Praveen Haranath

Principal investigator

919866415551

indialungdoc@gmail.com