| CTRI Number |
CTRI/2025/11/097937 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the two mortality predictors in neurosurgical patients present in neurosurgery ICU for outcome |
|
Scientific Title of Study
|
Comparison of the optic nerve sheath diameter with, either
Glasgow coma scale-pupil or full outline of
unresponsiveness score, as predictor of clinical
outcomes in neurosurgical patients. |
| 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 Neeharika Arora |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room No 2062-D, Department of Anaesthesia, Rohilkhand Medical
College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077104070 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Rana |
| Designation |
Junior Resident 1 |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Anesthesiology
Rohilkhand medical college and hospital ,pilibhit bypass road ,Bareilly,UttarPradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077576090 |
| Fax |
|
| Email |
ranaashish1712@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Rana |
| Designation |
Junior Resident 1 |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Anesthesiology
Rohilkhand medical college and hospital ,pilibhit bypass road ,Bareilly,UttarPradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077576090 |
| Fax |
|
| Email |
ranaashish1712@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital,Pilibhit bypass road ,Bareilly ,Uttar Pradesh |
| 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 Neeharika Arora |
Neurosurgerical ICU |
2nd Floor,Rohilkhand Medical College and Hospital,Pilibhit bypass road ,Bareilly ,Uttar Pradesh
Bareilly
UTTAR PRADESH |
8077104070
docneehars@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RMCH BAREILLY UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted in ICU under neurosurgery department
Patients aged 20-60 years of age
Attendants giving consent to participate for the study
ASA-physical status1-1V
Patients anticipated to survive for at least 24 hrs. in ICU |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Full Recovery 3
Partial Recovery 2
No Recovery 1
Outcome as Death 0 |
Full Recovery 3
Partial Recovery 2
No Recovery 1
Outcome as Death 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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)
|
07/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To Compare Optic nerve sheath diameter(ONSD) with, either Glasgow Coma Scale- Pupil score(GCS-P) or Full Outline of Unresponsivenes Score(FOUR), as predictor of clinical outcomes in neurosurgical patients. |