| 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
|
|
|
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
|
|
|
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. |