| CTRI Number |
CTRI/2023/05/053187 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of consciousness status and longterm outcomes of head injury patients using different scoring systems- GCS vs GCS-P vs FOUR score. |
|
Scientific Title of Study
|
Glasgow coma scale (GCS), GCS-pupil score (GCS-P) and Full outline of Unresponsiveness (FOUR) Score in traumatic brain injury (TBI) patients: A comparative study of inter-observer variability and prognostic ability |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
manisha patlan |
| Designation |
junior resident |
| Affiliation |
AILL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA |
| Address |
Room No. 315, 3rd floor, PG hostel, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA
Room No. 315, 3rd floor, PG hostel, AIIMS, BATHINDA, 151001
Bathinda
PUNJAB
151001
India |
| Phone |
08168345516 |
| Fax |
|
| Email |
manishapatlan22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NAVNEH SAMAGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OD MEDICAL SCIENCES, BATHINDA |
| Address |
Room no: 139, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA
Room no: 139, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA
Bathinda
PUNJAB
151001
India |
| Phone |
8427264480 |
| Fax |
|
| Email |
navnehsamagh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANKITA DEY |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA |
| Address |
ROOM NO:141, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA
ROOM NO:141, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES BATHINDA
Bathinda
PUNJAB
151001
India |
| Phone |
9698506683 |
| Fax |
|
| Email |
ankitadeyslg@gmail.com |
|
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Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, AIIMS BATHINDA |
|
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Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIOLOGY AIIMS BATHINDA |
| Address |
All India Institute of Medical Sciences, Dabwali Road BATHINDA |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MANISHA PATLAN |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Department of Anaesthesiology and Critical Care
Bathinda
PUNJAB |
8168345516
manishapatlan22@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-S09||Injuries to the head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients >18 years of age admitted to the hospital with traumatic brain injury (TBI)
|
|
| ExclusionCriteria |
| Details |
1.Past History of TBI
2. Previous history of stroke or any other neurological event
3. Intracranial space occupying lesion (ICSOL)
4. Previous history of cataract surgery
5. Patient with periorbital edema
6. Spinal cord injury
7. Refusal of consent
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| to compare the best and easiest score for assessing patients with traumatic brain injury. GOS-E at the time of discharge and 3 months after injury. |
time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GOS-E at the end of 3 months after injury |
3 months |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2023 |
| Date of Study Completion (India) |
23/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
all cases of Traumatic brain injury coming to the emergency department/ICU will be enrolled as per the inclusion and exclusion criteria. GCS, GCS-P and FOUR score will be assessed by a resident doctor and nursing officer in separate proforma. GOS-E score will be assessed at the time of discharge and 3 months post discharge. the study aims to compare the three scores as to which is most easier to use by comparing the data from doctors and nursing officers and also which score corelates with prognosis in a better way. score with least inter-observer variability and most corelation with prognosis will be considered better than the other two scores. since assessing the status of TBI patients is necessary to determine prognosis. also, anyone attending the patient (doctor or nursing staff) should be able to assess such patients with ease and accurately as well for early management and intervention. |