| CTRI Number |
CTRI/2024/02/062889 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Electrical Impedance Tomography for lung imaging |
|
Scientific Title of Study
|
Development of low-cost, portable, wearable full upper body EIT system for pulmonary function testing |
| Trial Acronym |
NIL |
|
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, Indian Institute of Technology Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7310670867 |
| Fax |
|
| Email |
mayankfph@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, Indian Institute of Technology 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, Indian Institute of Technology 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 = 2 |
| 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
Hardwar
UTTARANCHAL |
7895973469
ruchi.pulm@aiimsrishikesh.edu.in |
| Dr Mayank Goswami |
IIT Roorkee |
Department of physics
Room number 112, department of physics, IIT Roorkee
Hardwar
UTTARANCHAL |
7310670867
mayankfph@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 (IHEC) Indian Institute of Technology, Roorkee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy persons |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EIT for lung imaging |
age group 18-70 years Duration of single measurement: 20 sec Frequency |
| Intervention |
EIT |
age group 18-70 years Duration of single measurement: 20 sec Frequency: 3 measurements per person. Total time: one minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
age group 18 to 70 years |
|
| ExclusionCriteria |
| Details |
contradicting to spirometry are 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 weeks |
|
|
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)
|
29/02/2024 |
| 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
|
Indian patients and volunteers are allowed only. |