| CTRI Number |
CTRI/2018/12/016778 [Registered on: 26/12/2018] Trial Registered Prospectively |
| Last Modified On: |
21/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
retro prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Pattern of Head Injuries in Road Traffic Accident and its effect on "person who met with Accident" |
|
Scientific Title of Study
|
Epidemiological pattern and impact of head injuries in road traffic accident victims |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpa Pateria |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health , MAHE |
| Address |
Department of Masters in Hospital Administration, Prasanna School of
Public Health, Manipal Academy of
Higher Education, Manipal–
Udupi
KARNATAKA
576104
India |
| Phone |
9921748348 |
| Fax |
|
| Email |
drshilpapateria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kamath |
| Designation |
Asst. Professor Prasanna School of Public Health,MAHE |
| Affiliation |
Master’s in Hospital Administration, Prasanna School of Public Health, MAHE |
| Address |
Department of Masters in Hospital Administration Prasanna School of Public Health,
Manipal Academy of Higher
Education, Manipal – 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7760218342 |
| Fax |
|
| Email |
rajeshkamath82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kamath |
| Designation |
Asst. Professor Prasanna School of Public Health,MAHE |
| Affiliation |
Master’s in hospital Administration, Prasana School of Public Health, MAHE |
| Address |
Department of Masters in Hospital Administration, Prasanna School of Public Health,
Manipal Academy of Higher
Education,Manipal – 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7760218342 |
| Fax |
|
| Email |
rajeshkamath82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical Hospital Manipal as they provide Staff support and Medical Record Section Kasturba Hospital Manipal as they will provide Data, Files and Time. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
N/A |
| 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 |
| shilpa pateria |
Kasturba Hospital |
OPD block,Department of Neaurosurgey, Dhanvantri Complex,Kasturba Hospital,Madhav Nagar,Manipal,Udupi-576104 Karnataka
Udupi
KARNATAKA |
9921748348
drshilpapateria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutinal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-S09||Injuries to the head, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
: 1. All road traffic accident victims with head injury who visited the tertiary care trauma center.
2. Completed medical records.
3. All the victims of road traffic accident with head injury of last 1 year time period [Aug 2017- July 2018], Who will come for follow up in Out patient Department neurosurgery , for prospective questionnaire
|
|
| ExclusionCriteria |
| Details |
1. Patients with incomplete medical records.
2. Brought dead cases.
3. Patients discharged against medical advice
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
After collecting data :Age, gender, admission, diagnosis, time of admission, treatment and discharge, length of hospital stay, Glasgow Coma Scale of patient.
Dependent Variable-Treatment outcome of patient admitted with road traffic accident with head injury.
by questionnaire and proforma, analysis of data will be doneAll variables will be analysed, calculated and presented by tables and charts. Interpretation will be done. |
6 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPILICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
26/12/2018 |
| 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="0"
Months="5"
Days="23" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Road
traffic injuries are recognized, globally, as a major public health problem for
being one of the leading causes of deaths, disabilities and hospitalization,
imposing huge socio-economic costs.In case of India, road injuries is one of
the top four leading causes of death and health loss.During the calendar year
2016, the total number of road accidents is reported as 4,80,652 causing
injuries to 4,94,624 persons and claiming 1,50,785 lives in the country. This would
translate,on an average into 1317 accidents and 413 accident deaths taking
place on Indian roads every day or 55 accidents and 17 deaths every hour. According
to a survey, in India, Karnataka state is in the third position with 44011
total accidents, with 10856 deaths and 56971 injured cases.[1] Head
Injury is recognized as a major public health problem and those due to road traffic
accidents account for a great majority world wide. Among all the road traffic
accidents, 67 percentage are of head injury.
This
study had been designed to evaluate the epidemiological pattern of head
injuries and impact of it on road traffic accident trauma patients attending
trauma centre tertiary care teaching hospital serving a population of 165000, situated in Udupi district in the
southwest Indian state of Karnataka.
|