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CTRI Number  CTRI/2024/03/063607 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Measurement of Lung Injuries on CT in Trauma Patients 
Scientific Title of Study   Quantification and Grading of Pulmonary Contusions on CT in Polytrauma Patients 
Trial Acronym  QuPaC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharon Joy 
Designation  Post Graduate Resident 
Affiliation  Christian Medical College, Vellore 
Address  Department of Radiodiagnosis Christian Medical College Hospital, Vellore, Tamil Nadu India

Vellore
TAMIL NADU
632004
India 
Phone  9944660332  
Fax    
Email  sharon.joy2014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kirthi Sathyakumar 
Designation  Associate Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Radiodiagnosis Christian Medical College Hospital, Vellore, Tamil Nadu India

Vellore
TAMIL NADU
632004
India 
Phone  8489014491  
Fax    
Email  kirthi86sk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kirthi Sathyakumar 
Designation  Associate Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Radiodiagnosis Christian Medical College Hospital, Vellore, Tamil Nadu India

Vellore
TAMIL NADU
632004
India 
Phone  8489014491  
Fax    
Email  kirthi86sk@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore 
 
Primary Sponsor  
Name  Christian Medical College, Vellore 
Address  Christian Medical College, Hospital Town campus, Vellore Tamil Nadu India - 632004 
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 Sharon Joy  Christian Medical College  Department of Radiodiagnosis, Vellore, Tamil Nadu India
Vellore
TAMIL NADU 
9944660332

sharon.joy2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Christian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S273||Other and unspecified injuries oflung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consecutive patients with blunt trauma admitted under Trauma Services, with CT within 24 hours of admission. 
 
ExclusionCriteria 
Details  1 Death within first 48 hours of admission (unless it is isolated chest injury)

2 Intubated due to head injury

3 Non responder and Transient responders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To precisely quantify pulmonary contusion size on CT and develop a severity grading system  Lung contusion measurement done on the CT taken within 24 hours of admission post trauma 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate contusion size & severity with outcomes (such as pneumonia, ARDS, mortality, need for non-invasive ventilation or ventilator use, ICU stay)

To develop a severity scale for pulmonary contusion (mild / moderate / severe)

To determine the threshold contusion size predicting complications

To compare simple visual quantification of pulmonary contusion size with the primary semi-automated CT quantification
 
CT done within 24 hours of admission post trauma

Above mentioned clinical outcomes recorded during the course of the patients hospital stay 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   08/03/2024 
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="0"
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  

BACKGROUND

Pulmonary contusion is the most common chest injury with high mortality (10–20%) in polytrauma patients [Hosseini et al]. It is a significant contributor to the risk of respiratory complications such as ARDS and pneumonia in trauma patients. According to the literature, the majority of pulmonary contusions are only apparent on a chest CT. Trauma surgeons will be able to identify high-risk populations by using computed tomography (CT) to precisely quantify pulmonary contusion. A universal technique that properly measures pulmonary contusion may improve the accuracy of predicting outcomes and assist surgeons in determining what pulmonary contusion size identifies a patient at risk for complications. Hence, we aimed to determine the relationship between the percentage of pulmonary contusion volume and patient outcomes and to formulate a severity grading scale.

 

METHODS:

This will be a retrospective observational study of patients admitted under Trauma Surgery Unit of Christian Medical College, Vellore. We will include polytrauma patients (>18 years of age), diagnosed to have pulmonary contusion by chest CT done within 24 hours of admission and opted for treatment under Trauma Surgery Unit.  Those patients who do not have a chest CT within 24 hours or those who died within 48 hours of admission will be excluded from the study. Non-responders and transient responders and those who have been intubated due to head injury will also be excluded from the study. Chest CT of these patients with pulmonary contusion will be analysed using AW server software available in the Department of Radiodiagnosis. Pulmonary contusion volume and total lung volume will be measured and subsequently, the percentage volume of contusions will be obtained. We will also use a simple visual assessment method to quantify contusion size into 5 scores after reviewing both the lungs as a whole. A study specific CRF will be filled, which includes demographic details, mechanism of injury, injury severity (ISS, chest AIS). We will also document the outcomes to be analysed such as oxygen requirement, mechanical ventilator application duration, length of hospital stay, length of ICU stay, pneumonia, ARDS, in-hospital mortality from the patient charts and clinical workstation.

 

RESULTS:

Using multivariate analysis, we will attempt to correlate the outcomes with the pulmonary contusion volume percentage. We will then formulate a severity grading scale for the same.

 

 

 

 


 
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