| CTRI Number |
CTRI/2024/02/062859 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of the pattern and management of blunt chest injuries in tertiary care hospital |
|
Scientific Title of Study
|
Study of the pattern and management of blunt chest injuries in tertiary care hospital: a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HIMALI ANILBHAI DAVE |
| Designation |
2ND YEAR GENERAL SURGERY RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
403 PG3 Hostel SIR T Hospital campus, Kalanala, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7016471630 |
| Fax |
|
| Email |
himaliadave@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Rajan B Somani |
| Designation |
Associate Professor |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
DEPARTMENT OF GENERAL SURGERY,
Government Medical College & Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825572796 |
| Fax |
|
| Email |
somanirajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HIMALI ANILBHAI DAVE |
| Designation |
2ND YEAR GENERAL SURGERY RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
403 PG3 Hostel SIR T Hospital campus, Kalanala, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7016471630 |
| Fax |
|
| Email |
himaliadave@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College,Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Government Medical College Bhavnagar |
| Address |
KALANALA,PANWADI ROAD,BHAVNAGAR |
| 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 Himali Dave |
Government Medical College And Sir T Hospital, Bhavnagar |
Department of General Surgery,2nd floor new hospital building
Bhavnagar
GUJARAT |
7016471630
himaliadave@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Government Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S272||Traumatic hemopneumothorax, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with blunt chest injuries
Patients of accidental chest injury due to
vehicular accident and fall from height
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the severity, age, sex and mode of injury of blunt chest trauma patients |
over the time of admission period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to evaluate the type of management required in blunt chest trauma patients according to the severity, age, sex & mode of injury
|
over the time of admission period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/02/2024 |
| 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="3"
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
|
Trauma is an important and serious problem of public health concern. It leads to disability and mortality especially among most active and productive age group. Trauma to chest can lead to damage to internal organs like heart, lungs and other tissues of chest thereby threatening and endangering the life of injured person. we try to evaluate the pattern of blunt chest trauma with distribution of age, sex and mode of injury and observe the management required for the same to prevent/ correct it. |