| CTRI Number |
CTRI/2024/06/068913 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lung Transplant Calculator |
|
Scientific Title of Study
|
Lung Transplant eligibility among Out patient at Tertiary Care respiratory centre: assessment using a novel web based calculator |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Tyagi |
| Designation |
Professor |
| Affiliation |
AICTS/AFMC |
| Address |
Department of Respiratory Medicine
Army Institute of Cardiothoracic Sciences
KOTHRUD ROAD
OPP NEW COMMAND HOSPITAL
Pune
MAHARASHTRA
411040
India |
| Phone |
7798575844 |
| Fax |
|
| Email |
rahultyagi4960@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Tyagi |
| Designation |
Professor |
| Affiliation |
AICTS/AFMC |
| Address |
Department of Respiratory Medicine
Army Institute of cardiothoracic Sciences
KOTHRUD ROAD
OPP NEW COMMAND HOSPITAL
Pune
MAHARASHTRA
411040
India |
| Phone |
7798575844 |
| Fax |
|
| Email |
rahultyagi4960@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Tyagi |
| Designation |
Professor |
| Affiliation |
AICTS/AFMC |
| Address |
department of Respiratory Medicine
Army Institute of Cardiothoracic Sciences
KOTHRUD ROAD
OPP NEW COMMAND HOSPITAL
Pune
MAHARASHTRA
411040
India |
| Phone |
7798575844 |
| Fax |
|
| Email |
rahultyagi4960@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College
Opp race course,Sholapur Road, Pune Maharashtra 411040 India |
|
|
Primary Sponsor
|
| Name |
Armed forcres medical college pune |
| Address |
Opp Race Course, Sholapur Road,Pune-411040 India |
| Type of Sponsor |
Government medical college |
|
|
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 Rahul tyagi |
Army Institute of Cardiothoracic Sciences |
Department of Respiratory Medicine
Army Institute of Cardiothoracic Sciences
KOTHRUD ROAD OPP NEW COMMAND HOSPITAL
OPP NEW COMMAND HOSPITAL
Pune
MAHARASHTRA |
7798575844
rahultyagi4960@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J432||Centrilobular emphysema, (2) ICD-10 Condition: J479||Bronchiectasis, uncomplicated, (3) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
advanced pulmonary disease: COPD, Bronchiectasis and Interstitial Lung disease
Patient reporting the Outpatient department
Patient with complete radiological and functional evaluation
|
|
| ExclusionCriteria |
| Details |
Non-consenting patient
Patient with an incomplete investigation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Eligibility for transplant |
5-30MINUTES
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the average time required to assess the eligibility of the patient for transplantation in an OPD setting using a novel web base software
|
1-30 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Type of study: Prospective observational trial •Hypothesis: •Aim and Objectives: To determine the eligibility for referral and listing for lung transplant amongst patients of Interstitial Lung Disease/Bronchiectasis/COPD reporting to a Tertiary Respiratory OPD •Objectives: Primary: To estimate the number of patients with Interstitial Lung Disease/Bronchiectasis/COPD reporting to a Tertiary Respiratory centre eligible for lung transplant as per referral and listing criteria as laid by ISHLT Secondary: To determine the average time required to assess the eligibility of the patient for transplantation in an OPD setting using a novel web base software •Study population: Patient with chronic lung disease requiring transplant •Sample Size:50 •Modality for enrolment of the patients: OPD •Inclusion and Exclusion criteria: Inclusion criteria: •Patients at least 18 years of with advanced pulmonary disease: COPD, Bronchiectasis and Interstitial Lung disease •Patient reporting the Outpatient department •Patient with complete radiological and functional evaluation •Consenting to undergo the study Exclusion criteria: •Non-consenting patient •Patient with an incomplete investigation •Methods: Assessment of patient using web based calculator •Tool for data collection: Web based application |