| CTRI Number |
CTRI/2025/03/081793 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
understanding lung contusion and its impact on chest injury treatment |
|
Scientific Title of Study
|
Evaluation of pulmonary contusion and its
impact on the management outcome in blunt
trauma chest |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Jindal |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of General Surgery, Level 3, D Block, Government Medical College and Hospital, Sector 32. Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8427169496 |
| Fax |
|
| Email |
akhiljindal97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha R Dalal |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of General Surgery, Level 3, D Block, Government Medical College and Hospital, Sector 32. Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121563 |
| Fax |
|
| Email |
ushadalalakd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha R Dalal |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of General Surgery, Level 3, D Block, Government Medical College and Hospital, Sector 32. Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121563 |
| Fax |
|
| Email |
ushadalalakd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital sector 32 chandigarh pincode 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32, Chandigarh, 160030 |
| Type of Sponsor |
Government 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 Akhil Jindal |
Government Medical College and Hospital |
Department of General Surgery ,Level 3, D Block, Government Medical College and Hospital, Sector 32. Chandigarh
160030
Chandigarh
CHANDIGARH |
8427169496
akhiljindal97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S29||Other and unspecified injuries ofthorax, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All cases of Blunt trauma Chest of Age 18 years and above |
|
| ExclusionCriteria |
| Details |
1. Patients not consenting to participate in the study
2. Penetrating chest injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of pulmonary contusion in blunt trauma chest |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of requirement of IV antibiotics, IV fluids, analgesia, Duration
in hospital stay, Intubation / NIV, Epidural analgesia, ICD and/or thoacotomy, ICU/CCU
admission, complications (ARDS, pneumonitis), 30 days morbidity and mortality |
Baseline, 30 days |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
15/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2025 |
| 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 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
|
82 consecutive patients meeting the inclusion and exclusion criteria and giving written informed consent for participation in the study shall be recruited. All of the enrolled blunt chest trauma patients’ pertinent data will be gathered in accordance with the proforma. Age and sex, mode of injury (RSA, fall from height, assault, and animal attack), symptoms, and comprehensive demographic and clinical characteristics (cough, chest pain, blood-streaked sputum, shortness of breath) will be assessed in all patients meeting inclusion criteria. Any concomitant illnesses, such as chronic obstructive lung disease,Tuberculosis, hypertension, diabetes mellitus, prior pneumonia, coronary artery disease, and chronic renal failure will be noted and their effects on the course of the patient’s condition will be also analyzed. A general physical examination will be performed, along with local examination findings (tachypnoea, ecchymosis, chest wall tenderness, subcutaneous emphysema, wheezing, and crepitations).Blood investigations including hemogram, serum electrolytes, renal function tests and arterial blood gas analysis, will be carried out at the time of admission and will be repeated as and when required. Radiological investigations including Chest radiographs (AP/PA view), E-FAST/ ultrasonography and NCCT/CECT chest for lung window will be obtained for all the patients.Immediately after admission, patient will be managed with iv fluids, analgesics, broad spectrum antibiotics and /or oxygen therapy. In patients with pneumothorax and hemothorax tube thoracostomy will be done. The patients of severe trauma with flail chest notmaintaining oxygen saturation will be managed by mechanical ventilation along with any surgical intervention (tracheostomy / thoracotomy) if required. Complications if any(pneumonia, empyema, ARDS, COPD exacerbation, MODS, septicemia) during the course of hospital stay will be noted.Result will be consolidated, and the outcome will be correlated with the incidence. Outcome will be studied on the basis of: - requirement of IV antibiotics, IV fluids, analgesia, Duration in hospital stay, Intubation / NIV, Epidural analgesia, ICD and/or thoacotomy, ICU/CCU admission, complications (ARDS, pneumonitis), 30 days morbidity and mortality.
|