| CTRI Number |
CTRI/2024/03/064578 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Characteristics of respiratory system in COVID-19 survivors in CT scan |
|
Scientific Title of Study
|
Functional characteristics assessment of respiratory system in COVID-19 survivors using Quantitative Computed Tomography |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Winniecia Dkhar |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Medical Imaging Technology
Manipal College of Health Professions
Manipal Academy of Higher Education,Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8095372184 |
| Fax |
|
| Email |
winniecia.dkhar@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Winniecia Dkhar |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Medical Imaging Technology
Manipal College of Health Professions
Manipal Academy of Higher Education,Manipal
KARNATAKA 576104 India |
| Phone |
8095372184 |
| Fax |
|
| Email |
winniecia.dkhar@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Winniecia Dkhar |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Medical Imaging Technology
Manipal College of Health Professions
Manipal Academy of Higher Education,Manipal
KARNATAKA 576104 India |
| Phone |
8095372184 |
| Fax |
|
| Email |
winniecia.dkhar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Radiodiagnosis and Imaging, Kasturba Hospital, Manipal-576104,
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Aacademy of Higher Education, Manipal |
| Type of Sponsor |
Private 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 Suresh S |
Kasturba Hospital |
Room No 3 Department
of Radio diagnosis and
Imaging Kasturba
Hospital Madhav Nagar
Manipal
Udupi
KARNATAKA Udupi KARNATAKA |
9886118811
suresh.sugumar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patient must be of an adult of age between 18 years and 60 years old.
Must have an history of positive RT-PCR test.
|
|
| ExclusionCriteria |
| Details |
Data will be excluded from individuals with poor breath-hold capacity.
Intubated, bedridden patients which led to poor image quality with motion artifacts in the images also must be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lung Density in Hounsefield unit
Airway Measurements in cm |
On completion of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lung volume
Emphysema volume |
On completion of data collection |
|
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
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)
|
01/04/2024 |
| 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="1" 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
|
Quantitative CT analysis is one area in the rapidly growing field of radiomics, the practice of extracting, analyzing, and interpreting quantitative data from medical images to aid in disease diagnosis and prognosis. The majority of quantitative tools are based on volumetric datasets. There is a wide range of information that can be extracted from the data in different ways. However, one of the most important aspects of quantitative CT analysis is the ability to generate accurate 3D models that can be used to make accurate and precise measurements of the various structures of interest.Objective(s) of the study: To assess the functional characteristics of the respiratory system of COVID-19 survivors using Quantitative Computed Tomography. Materials and method: Patients who have been advised for HRCT will be recruited for the study. After screening of patient through all the inclusive and exclusive criteria, informed consent will be obtained. The participant is inquired about any history of COVID-19 and a written consent is obtained, which explains the scan that is to be done for the respective patient. A non-enhanced HRCT chest CT scan will be performed for the study. The source data will be reconstructed and performed with a slice thickness of 1.00mm and with an increment of 0.500mm with a preset window in the lung as well as in the mediastinal, with a matrix size of 512x512. Later the data will be launched in the COPD application in the Philips IntelliSpace space software, version 10.1. The images are then opened in the multiple modules in the COPD software to render multiple measurements of each lobe of the lungs. The 3D images of the lungs and the airways are created in the verified citation module and each airway, lobe, and lung can be isolated as per choice. The lung density modules enable to measurement of the density of the lungs in Hounsfield units and the threshold can be altered as needed for assessment. Measuring Volumetric measurements of the lungs which are tabulated under different titles of emphysema volume threshold, total volume, and emphysema ratio threshold. These aforementioned titles will also be available in percentiles as well. Airway extraction module aids in assessing the 3D rendered volume of the airways ie., the trachea, bronchus, and bronchioles.
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