| CTRI Number |
CTRI/2026/02/102850 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of Eye ultrasound Measurements with Neurological Outcome in Traumatic Brain Injury Patients |
|
Scientific Title of Study
|
A Prospective Observational Study for evaluation of prognostic value of Optic Nerve Sheath Diameter (ONSD),Eyeball Transverse Diameter (ETD) and Optic Nerve Sheath Diameter/Eyeball Transverse Diameter (ONSD/ETD) ratio and it’s correlation with neurological outcome in traumatic brain injury patients admitted in ICU. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVANGI BADJATYA |
| Designation |
Junior Resident |
| Affiliation |
IMS,BHU |
| Address |
Department of Anaesthesiology,IMS,BHU,Varanasi,UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8005318013 |
| Fax |
|
| Email |
shivangibadjatya1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANJAREE MISHRA |
| Designation |
Professor |
| Affiliation |
IMS,BHU |
| Address |
Department of Anaesthesiology,IMS,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452030626 |
| Fax |
|
| Email |
mnajari@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MANJAREE MISHRA |
| Designation |
Professor |
| Affiliation |
IMS,BHU |
| Address |
Department of Anaesthesiology,IMS,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452030626 |
| Fax |
|
| Email |
mnajari@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi , India ,
Pin code -221005 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology,IMS,BHU |
| Address |
IMS,BHU,Varanasi |
| 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 |
| SHIVANGI BADJATYA |
IMS,BHU |
Department of Anaesthesiology
IMS,BHU
Varanasi
UTTAR PRADESH |
8005618013
shivangibadjatya1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S09||Other and unspecified injuries ofhead, (2) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Relatives giving written informed consent
Patients of traumatic brain injury admitted in ICU within 48 hrs |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Age more than 65 years
Consent refusal
Orbital trauma
Pre-existing ocular diseases
Other neurological diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glasgow outcome scale
ICU length of stay
|
At day 14 of ICU admission
At day 28 of ICU admission |
|
|
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)
|
14/02/2026 |
| 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 Applicable |
| 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
|
This prospective observational study aims to evaluate the prognostic value of Optic Nerve Sheath Diameter (ONSD), Eyeball Transverse Diameter (ETD), and the ONSD/ETD ratio, measured using ultrasound, in predicting neurological outcomes in traumatic brain injury (TBI) patients admitted to the ICU. Because ONSD varies with age, sex, and individual anatomical differences, combining ONSD with ETD to form the ONSD/ETD ratio may provide a more reliable estimate of raised intracranial pressure (ICP). The study fills a gap in existing literature by integrating these ultrasound parameters with established clinical and radiological scoring systems—GCS, ISS, Rotterdam CT Score, and GOS. A total of 100 adult TBI patients (18–65 years) admitted within 48 hours will be evaluated on Day 1 and Day 7 using ultrasound to measure ONSD, ETD, and their ratio. Neurological outcomes will be assessed using the Glasgow Outcome Scale (GOS), with secondary analysis of ICU stay duration and mortality. Statistical analysis will include ROC curves, sensitivity, specificity, and correlation tests to determine predictive accuracy. |