| CTRI Number |
CTRI/2024/01/061582 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of patients with blunt chest trauma at Tertiary Care Centre |
|
Scientific Title of Study
|
Clinical profile and management of blunt chest trauma patients at tertiary care centre- a cross sectional 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 |
Dr Aishwarya Gupta |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College |
| Address |
General Surgery Department, Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly (U.P.) 243006 INDIA
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
07668988188 |
| Fax |
|
| Email |
aishwaryaagupta17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjul Mohan |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
General Surgery Department, Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly (U.P.) 243006 INDIA
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9897524885 |
| Fax |
|
| Email |
manjul.2710@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjul Mohan |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
General Surgery Department, Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly (U.P.) 243006 INDIA
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9897524885 |
| Fax |
|
| Email |
manjul.2710@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly (U.P.) 243006 INDIA |
| 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 Aishwarya Gupta |
Rohilkhand Medical College and Hospital |
Department of General Surgery Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly (U.P.) 243006 INDIA
Bareilly
UTTAR PRADESH |
07668988188
aishwaryaagupta17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committe,Rohilkhand Medical college and hospital,Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S20-S29||Injuries to the thorax, (2) ICD-10 Condition: S211||Open wound of front wall of thoraxwithout penetration into thoracic cavity, (3) ICD-10 Condition: S225||Flail chest, (4) ICD-10 Condition: S202||Contusion of thorax, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All cases of isolated chest trauma, and chest trauma with other associated injuries admitted in our hospital during the study period |
|
| ExclusionCriteria |
| Details |
1. All patients less than 18years of age, or more than 60 years of age
2. All mediastinal and cardiac injuries, medical cause , penetrating injury. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the outcome in patients with blunt chest trauma through the mechanism of injury and different management stratergies. |
1st follow-up one month.
2nd follow-up 3 months
3rd follow up- 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/01/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Although there have been advancements in the treatment of trauma in critical care, chest trauma remains a significant cause of illness and death among otherwise healthy individuals.In developed nations, chest trauma is responsible for 20-25% of deaths, making it a major contributor to mortality rates. The severity and type of chest injury, and other associated injuries like head injury, abdominal injury, and extremity injury, all contribute to the morbidity and mortality associated with chest trauma. As the incidence of morbidity and mortality following chest trauma is increasing, with the availability of E-FAST, High resolution Computed Tomography of Thorax and chest x-ray, early intervention will be life saving. Thus, the need for this study.
|