| CTRI Number |
CTRI/2023/12/060876 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Process of Care Changes
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Electrical Impedance Tomography for lung imaging |
|
Scientific Title of Study
|
Development of Electrical Impedance Tomography system and its applications |
| Trial Acronym |
EIT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Goswami |
| Designation |
Associate Professor |
| Affiliation |
IIT ROORKEE |
| Address |
Room number 112, department of physics, IIT Roorkee
Room number 112, department of physics, IIT Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
|
| Fax |
|
| Email |
mayank.goswami@ph.iitr.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishali Sharma |
| Designation |
Research Scholar |
| Affiliation |
IIT ROORKEE |
| Address |
Room number 112, department of physics, IIT Roorkee
Room number 112, department of physics, IIT Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
09672073153 |
| Fax |
|
| Email |
v_sharma@ph.iitr.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Sharma |
| Designation |
Research Scholar |
| Affiliation |
IIT ROORKEE |
| Address |
Room number 112, department of physics, IIT Roorkee
Room number 112, department of physics, IIT Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
09672073153 |
| Fax |
|
| Email |
v_sharma@ph.iitr.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) with proposal ID: IIRP-2023-0656 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian council of medical Research |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Dua |
AIIMS Rishikesh |
Department of Pulmonary medecine AIIMS Rishikesh, Rishikes
Hardwar
UTTARANCHAL |
09672073153
ruchi.pulm@aiimsrishikesh.edu.in |
| Mayank Goswami |
IIT Roorkee |
Room number 112, department of physics, IIT Roorkee
Hardwar
UTTARANCHAL |
09672073153
mayank.goswami@ph.iitr.ac.in |
| Vaishali Sharma |
IIT Roorkee |
Room number 112, department of physics, IIT Roorkee
Hardwar
UTTARANCHAL |
09672073153
v_sharma@ph.iitr.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
| Institute human ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy persons |
| Patients |
(1) ICD-10 Condition: J00-J06||Acute upper respiratory infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EIT for lung imaging |
age group 18-70 years
Duration of single measurement: 20 sec
Frequency: 3 measurements per person.
Total time: one minute |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
a) Normal -< 10 Pack years and with respiratory symptoms
b) Age group 18-70 years old
c) Diseased-obstructive or restrictive pathology and Able to perform spirometry/DLCo and body box
|
|
| ExclusionCriteria |
| Details |
Contraindications to spirometry/Q-box not consenting. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PEEP might vary range from 9–13 cm H2O |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function. lung volume might vary range from 4 to 6 L |
5 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
N/A |