| CTRI Number |
CTRI/2018/08/015237 [Registered on: 08/08/2018] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Device validation study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical validation of respiratory medical device and its correlation with clinical tests and diagnosis |
|
Scientific Title of Study
|
Respiratory sound analysis and correlation with clinical tests and clinical diagnosis |
| Trial Acronym |
Salcit Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SALCIT/2018/001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Praveen Haranath |
| Designation |
Consultant Intensivist and Consultant Pulmonologist |
| Affiliation |
Apollo Hospitals |
| Address |
Apollo Hospitals Jubilee Hills Hyderabad
Hyderabad
ANDHRA PRADESH
500096
India |
| Phone |
|
| Fax |
|
| Email |
indialungdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Narayana Rao Sripada |
| Designation |
Chief Executive Officer |
| Affiliation |
SALCIT TECHNOLOGIES PRIVATE LIMITED |
| Address |
Flat No 2408 Sai Dream Castle Apartment Nizampet Road KUKATPALLY
Hyderabad Telangana
Hyderabad
ANDHRA PRADESH
500090
India |
| Phone |
919945399533 |
| Fax |
|
| Email |
svnnrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Narayana Rao Sripada |
| Designation |
Chief Executive Officer |
| Affiliation |
SALCIT TECHNOLOGIES PRIVATE LIMITED |
| Address |
Flat No 2408 Sai Dream Castle Apartment Nizampet Road KUKATPALLY
Hyderabad Telangana
Hyderabad
ANDHRA PRADESH
500090
India |
| Phone |
919945399533 |
| Fax |
|
| Email |
svnnrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| SALCIT TECHNOLOGIES PRIVATE LIMITED, Flat No 2408, Sai Dream Castle Apartment, Nizampet Road,KUKATPALLY,
Hyderabad, Telangana, 500090 |
|
|
Primary Sponsor
|
| Name |
SALCIT TECHNOLOGIES PRIVATE LIMITED |
| Address |
Flat No 2408, Sai Dream Castle Apartment, Nizampet Road,KUKATPALLY,
Hyderabad, Telangana, 500090 |
| Type of Sponsor |
Other [IT COMPANY WHICH IS INTO HEALTH CARE SERVICES] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sai Praveen Haranath |
Apollo Hospital |
Room No 9054, Pulmonology Department, Basement 01, Main block, Apollo Hospitals, Jubilee Hills
Hyderabad
ANDHRA PRADESH |
919866415551
indialungdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Clinical Studies (IEC-CS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Written signed and dated informed consent (patient or LAR)
2. Either gender with age 18 years and above.
3. Subjects suffering with CRD’s, Pulmonary Tuberculosis, CHF and Pulmonary Fibrosis. |
|
| ExclusionCriteria |
| Details |
1. Subjects who require ventilation, flow of oxygen must be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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
|
| Outcome |
TimePoints |
| 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. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2018 |
| Date of Study Completion (India) |
09/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |