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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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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