| CTRI Number |
CTRI/2024/06/069057 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of age, sex, time required to reach hospital and admission pattern to different department at Trauma Centre |
|
Scientific Title of Study
|
Demographic profile and admission pattern at Tertiary Care Trauma Centre-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 |
Abhay Narayan Sharma |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi |
| Address |
Department of Anesthesiology, First Floor, Sir Sunderlal Hospital (SSH),Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7544910215 |
| Fax |
|
| Email |
abhaysha8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Professor |
| Affiliation |
IMS BHU Varanasi |
| Address |
Department of Anesthesiology, First Floor, Sir Sunderlal Hospital (SSH),Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi
Department of Anesthesiology, First Floor,Sir Sunderlal Hospital (SSH),Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashtrauma@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Professor |
| Affiliation |
IMS BHU Varanasi |
| Address |
Department of Anesthesiology, First Floor, Sir Sunderlal Hospital (SSH),Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi
Department of Anesthesiology, First Floor, Sir Sunderlal Hospital (SSH),Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashtrauma@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Trauma Centre, Department of Anesthesiology IMS BHU Varanasi-221005, India |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Trauma Centre, Department of Anesthesiology, Institute of Medical Sciences (IMS), Banaras Hindu University (BHU), Varanasi-221005, India |
| 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 |
| Abhay Narayan Sharma |
Trauma Centre BHU |
Trauma Centre, Department of Anesthesiology, IMS BHU
Varanasi
UTTAR PRADESH |
7544910215
abhaysha8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Faculty of Medicine, IMS BHU, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients who had sustained trauma through RTA,
fall from height or level ground.
2.Trauma related to assault.
3.Trauma related to sports and from animals.
4.Trauma related to burns, industrial incidents,
electrical injuries |
|
| ExclusionCriteria |
| Details |
1.Patients already dead-on arrival.
2.Patients with non-trauma type complaints.
3.Patient who refused consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Demographic profile
Admission pattern
Time to reach emergency dept
Emergenvy to concerned department desposition time
severity of injury |
at time of trauma emergency visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/06/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Study will be carried out in patients who will be admitted in the tertiary care trauma centre, IMS BHU.Data will be collected from the patient/relative and from admission record. Data will be collected in the form of age and sex of patient, date and time of injury, date and time of emergency room visit, date and time of admission to concern department, severity of injury - Glassgow Coma Scale, Revised Trauma Score, Injury Severity Score. Medicolegal status, Diagnosis and Final disposition of patient (number of patients got admission, number of patients waited for more than 24hrs, LAMA). Trauma patients will be separated according to speciality.Results will be analysed under each category to find out percentage of admissions of each discipline. Disposition of patient will be recorded in terms of transfer to speciality like trauma surgery,orthopaedics,OMFS,plastic surgery,neurosurgery,ICU. |